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Found 7 results
510(k) Data Aggregation
K Number
K091769Device Name
TRUST DAM
Manufacturer
LINE ONE LABORATORIES, INC.
Date Cleared
2010-02-05
(234 days)
Product Code
MSC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
LINE ONE LABORATORIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Line One Trust Dam is used as a barrier when engaging in oral/vaginal sex and oral/anal sex to help reduce the transmission of bodily fluids, harmful germs, and sexually transmitted diseases.
Device Description
This oral dam is made of natural rubber latex, which completely covers a person's pubic areas during oral genital stimulation. This dam has a smooth surface (both sides), nominal lay flat width 154 mm, nominal length 250 mm, and nominal thickness 0.07mm. It is non- lubricated, and food grade cornstarch is used as a dressing material.
The condoms from which the oral dams are made conform to current established national and international voluntary standards which include ASTM D3492:2008; and have been previously cleared by the USFDA (ref: K070830).
The condoms will be offered in the following Colors and Flavors:
1. Yellow Banana
2. Red Strawberry
3. Green Mint
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K Number
K991892Device Name
TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR
Manufacturer
LINE ONE LABORATORIES
Date Cleared
1999-08-19
(77 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
LINE ONE LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Device is A latex Condom: designed to Prevent PREGNANCY & help reduce the Risk. OF TRANSMISSION TO sexually transmitted diseases.
Device Description
latex Condom
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K Number
K970633Device Name
TUSTEX FLAVORED CONDOMS
Manufacturer
LINE ONE LABORATORIES
Date Cleared
1997-03-21
(29 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
LINE ONE LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K964598Device Name
TRUSTEX COLA FLAVORD CONDOM
Manufacturer
LINE ONE LABORATORIES
Date Cleared
1997-02-14
(88 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
LINE ONE LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K964599Device Name
TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR
Manufacturer
LINE ONE LABORATORIES
Date Cleared
1997-02-14
(88 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
LINE ONE LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K964591Device Name
TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR
Manufacturer
LINE ONE LABORATORIES
Date Cleared
1997-02-13
(90 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
LINE ONE LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K946103Device Name
TRUSTEX FLAVOR CONDON IN COLORS
Manufacturer
LINE ONE LABORATORIES & TRADING CO.
Date Cleared
1996-07-15
(579 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
LINE ONE LABORATORIES & TRADING CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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