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Found 6 results
510(k) Data Aggregation
K Number
K081236Device Name
K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME
Manufacturer
MCNEIL-PPC, INC.
Date Cleared
2008-09-25
(147 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
MCNEIL-PPC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Interections of 2-in-1 Massage Crème™ is a personal lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's in ural. lubrication. This product is compatible with latex condoms.
Device Description
This device is developed for non-therapeutic body massage and personal lubricant compatible with latex condom that imparts a warming sensation upon the skin.
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K Number
K072421Device Name
K-Y BRAND YOURS+MINE
Manufacturer
MCNEIL-PPC, INC.
Date Cleared
2008-03-06
(191 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
MCNEIL-PPC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
K-Y® Brand YOURS+MINE™ is intended as a personal lubricant for penile and vaginal application compatible with latex condom.
Device Description
The devices are personal lubricants compatible with latex condom.
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K Number
K072360Device Name
K-Y BRAND INTRIGUE INTENSE WARMING SENSATION
Manufacturer
MCNEIL-PPC, INC.
Date Cleared
2007-12-12
(112 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
MCNEIL-PPC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
K-Y® Brand Intrigue™ Intense Warming Sensation 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
K062535Device Name
K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING
Manufacturer
MCNEIL-PPC, INC.
Date Cleared
2007-01-26
(150 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
MCNEIL-PPC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
K-Y® Brand Touch Massage® 2-in-1 Tingling™ is intended as a body massage + personal IN-1 - Drain For penile and vaginal application compatible with latex condom.
Device Description
This device is a body massage + personal lubricant compatible with latex condom that has been specifically developed produce a tingling sensation and a minty scent.
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K Number
K053397Device Name
K-Y BRAND SENSUAL MIST
Manufacturer
MCNEIL-PPC, INC.
Date Cleared
2006-02-17
(73 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
MCNEIL-PPC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
K-Y® Brand SENSUAL MIST™ is intended as a personal lubricant (for penile and vaginal application) compatible with latex condom.
Device Description
This device is a condom compatible personal lubricant that has been specifically developed to be delivered via a non-aerosol spray pump.
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K Number
K023789Device Name
O.B. TAMPONS
Manufacturer
MCNEIL-PPC, INC.
Date Cleared
2002-12-06
(23 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
MCNEIL-PPC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
o.b.® Tampons are to be inserted into the vagina in order to absorb menstrual fluid.
Device Description
The device is a cotton/rayon pledget with a removal string. It is available in various absorbencies.
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