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510(k) Data Aggregation
K Number
K143349Device Name
Gynomunal
Manufacturer
POLICHEM S.A.
Date Cleared
2015-09-16
(296 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
POLICHEM S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Gynomunal is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and with polyisoprene condoms, but not with polyurethane condoms.
Device Description
Gynomunal is a non-sterile, water-based, ivory to slightly yellow personal lubricant with a shelflife of 36 months. Gynomunal device specifications include color, odor, pH, viscosity, osmolality, antimicrobial effectiveness (Compliance with USP <51>), and microbiological quality (Compliance with USP <61>, <62>, and <1111>).
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K Number
K112217Device Name
ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER
Manufacturer
POLICHEM S.A.
Date Cleared
2012-10-16
(441 days)
Product Code
NUC, MMS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
POLICHEM S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Me Again® Long Lasting Vaginal Moisturizer is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
vH Essentials® Long Lasting Vaginal Moisturizer is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Device Description
Long Lasting Vaginal Moisturizer is a non-sterile, non-greasy, water-based personal lubricant delivered in single-use, pre-filled vaginal applicators. Long Lasting Vaginal Moisturizer can be used daily to supplement the body's natural lubrication. Long Lasting Vaginal Moisturizer contains ingredients commonly found in cleared personal lubricants.
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K Number
K083087Device Name
ECOCEL
Manufacturer
POLICHEM S.A.
Date Cleared
2009-08-07
(295 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
POLICHEM S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ecocel® is a hydrosoluble lacquer indicated to protect intact or damaged nails from the effects of moisture, friction (rubbing) or shear (tearing), relieving symptoms and signs of nail dystrophy (i.e. nail splitting and fragility).
Device Description
Ecocel® is a water-soluble lacquer contained in a glass bottle (1.5 or 3.3 mL) with a nylon brush fitted on the polypropylene screw cap.
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