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Found 3 results
510(k) Data Aggregation
K Number
K043480Device Name
ENHANCE CLITORAL STIMULATION AID
Manufacturer
GYNAVATIONS, INC.
Date Cleared
2005-06-08
(174 days)
Product Code
NBV
Regulation Number
884.5970Why did this record match?
Product Code :
NBV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Enhance CSA is Indicated for women with the following symptoms of Female Sexual Arousal Disorder (FSAD): difficulty with arousal (and lubrication), sexual desire and ability to achieve orgasm.
Device Description
Not Found
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K Number
K001576Device Name
EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
Manufacturer
PROSURG, INC.
Date Cleared
2000-12-28
(220 days)
Product Code
NBV
Regulation Number
884.5970Why did this record match?
Product Code :
NBV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
DEN000006Device Name
EROS-CLITORAL THERAPY DEVICE (CTD)
Manufacturer
UROMETRICS, INC.
Date Cleared
2000-04-28
(1 days)
Product Code
NBV
Regulation Number
884.5970Why did this record match?
Product Code :
NBV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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