FDA 510(k), K092586, MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU
FDA 510(k), K092586, MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU
510(K) Number: K092586
Device Name: MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU
Manufacturer: INNOLATEX (THAILAND) LIMITED
Device Classification Name: Condom
Regulation Number: 884.5300
Classification Product Code: HIS
Date Received: 08/24/2009
Decision Date: 05/12/2010
Regulation Medical Specialty: Obstetrics/Gynecology
Total pages: 290
Fully redacted pages: 176
Content pages: 114
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