Search Results
Found 11 results
510(k) Data Aggregation
K Number
K070545Device Name
K-Y BRAND WARMING LIQUID
Manufacturer
PERSONAL PRODUCTS CO.
Date Cleared
2007-03-23
(25 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
PERSONAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
K-Y® Brand Warming Liquid is intended as a personal lubricant compatible with latex condom.
Device Description
This device is a condom compatible personal lubricant that has been specifically developed to produce a warming sensation when in contact with moist skin and mucosal membrane.
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K Number
K062796Device Name
K-Y BRAND INTRIGUE
Manufacturer
PERSONAL PRODUCTS CO.
Date Cleared
2006-12-08
(80 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
PERSONAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
K-Y® Brand Intrigue™ is intended as a personal lubricant for penile and vaginal application compatible with latex condom.
Device Description
This device is a personal lubricant compatible with latex condom.
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K Number
K021492Device Name
K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT
Manufacturer
PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC.
Date Cleared
2002-08-07
(90 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
PERSONAL PRODUCTS CO., DIV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Personal Lubricant (compatible with latex condoms)
Device Description
K-Y® Brand WARMING LIQUID is a non-sterile clear non-staining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity. K-Y® Brand WARMING LIQUID is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.
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K Number
K020827Device Name
K-Y BRAND ULTRA GEL PERSONAL LUBRICANT
Manufacturer
PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC.
Date Cleared
2002-06-12
(90 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
PERSONAL PRODUCTS CO., DIV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Personal Lubricant compatible with latex condoms, helps enhance intimacy
Device Description
K-Y® Brand Ultra Gel™ is a non-sterile water- based personal lubricant designed to supplement the body's own natural lubrication fluids. This formula is a clear, non-irritating, non-greasy, non-staining, high viscosity liquid gel. This highly lubricous product may be used with or without a latex condom during intimate sexual activity. K-Y® Brand Ultra Gel™ is not a contraceptive or spermicide. It is however, compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.
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K Number
K010365Device Name
ORTHO CONTROL FEMALE URINARY CONTROL DEVICE
Manufacturer
PERSONAL PRODUCTS CO.
Date Cleared
2001-04-30
(82 days)
Product Code
MNG
Regulation Number
876.5160Why did this record match?
Applicant Name (Manufacturer) :
PERSONAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990536Device Name
O.B. TAMPON
Manufacturer
PERSONAL PRODUCTS CO.
Date Cleared
1999-08-31
(193 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
PERSONAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
o.b. Tampons are used to absorb menstrual fluid or other vaginal discharge.
Device Description
o.b. ® Non-applicator Tampons are used to absorb menstrual fluid. The modified tampon will be available in the 15-18 gram syngyna absorbency range. o.b.® Non-applicator Tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
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K Number
K991118Device Name
O.B. APPLICATOR TAMPONS, O.B. TAMPONS
Manufacturer
PERSONAL PRODUCTS CO.
Date Cleared
1999-06-29
(89 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
PERSONAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
o.b. ® Tampons are used to absorb menstrual fluid or other vaginal discharge.
Device Description
o.b. ® non-applicator and applicator Tampons are used to absorb menstrual fluid. The modified tampon will be available in Regular, Super, and Super Plus syngyna absorbency ranges. o.b.® non-applicator and applicator Tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
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K Number
K974629Device Name
O.B. APPLICATOR AND NON-APPLICATOR TAMPONS
Manufacturer
PERSONAL PRODUCTS CO.
Date Cleared
1998-02-10
(60 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
PERSONAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
o.b. Tampons are used to absorb menstrual fluid or other vaginal discharge.
Device Description
o.b. ® tampons are used to absorb menstrual fluid or other vaginal discharge. These tampons will be available in regular, super and super plus absorbencies, and in applicator and non-applicator versions. o.b. ® non-applicator tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. o.b. ® applicator tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. The applicator consists of a cardboard laminate with a coating.
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K Number
K971589Device Name
REACH ANTIBACTERIAL TOOTHBRUSH
Manufacturer
PERSONAL PRODUCTS CO.
Date Cleared
1997-07-24
(84 days)
Product Code
EFW
Regulation Number
872.6855Why did this record match?
Applicant Name (Manufacturer) :
PERSONAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
REACH® Antibacterial Toothbrush is used to remove adherent plaque and food debris from teeth to reduce tooth decay. This device is made of a shaft (handle) with synthetic bristles attached at one end. An antibacterial agent has been added to the handle portion. The antibacterial activity is limited to the handle of the toothbrush.
Device Description
Both the modified device and the predicate device are manual toothbrushes consisting of a shaft with synthetic bristles at one end. Antibacterial agents have been incorporated into the devices.
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K Number
K970954Device Name
O.B. APPLICATOR TAMPONS
Manufacturer
PERSONAL PRODUCTS CO.
Date Cleared
1997-06-10
(85 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
PERSONAL PRODUCTS CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
o.b.® Applicator Tampons are inserted into the vagina to collect menstrual fluid. This is the same intended use as current commercial tampons.
o.b. applicator tampons are used to absorb mentrual fluid or other vaginal discharge.
Device Description
o.b.® Applicator Tampons are used to absorb menstrual fluid or other vaginal discharge. These tampons will be available in regular, super and super plus absorbencies.
o.b.® Applicator Tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
The applicator consists of a cardboard laminate with a coating.
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