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510(k) Data Aggregation
K Number
K990597Device Name
SUMMER'S EVE LUBRICATING JELLY
Manufacturer
Date Cleared
1999-07-19
(145 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
C.B. FLEET CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use as a personal lubricant to lubricate condoms and help ease insertion of tampons and douches. For OTC use.
Device Description
Not Found
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