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U.S. Department of Health and Human Services

510(k) Premarket Notification

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41 to 50 of 386 Results
ProductCode: HIS Decision Date To: 08/27/2018
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lifestyles, contempo or private label-male latex condom with desensitizing lubricant SURETEX, LTD. K030176 04/17/2003
lifestyles, contempo or private label strawberry, vanilla, or banana flavored condom SURETEX PROPHYLACTICS LTD. K000408 04/19/2000
royale brand latex condoms silicone lubricant colored-or assorted colors SURETEX PROPHYLACTICS (INDIA) LTD. K983320 12/11/1998
various ansell tradenames or private label SURETEX PROPHYLACTICS (INDIA) LTD. K992081 08/19/1999
headfirst (condom) STUAL PRODUCTS, INC. K874921 05/13/1988
safe SSN MEDICAL PRODUCTS SDN. BHD. K013773 01/24/2002
durex flavored latex condom SSL AMERICAS, INC. K032227 03/29/2004
durex latex condom with male genital desensitizer lubricant SSL AMERICAS, INC. K020659 03/29/2002
durex play lubricant SSL AMERICAS, INC. K032124 01/16/2004
durex spearmint scented lubricated latex condom (durex 'tingling pleasure' condom SSL AMERICAS, INC. K042470 04/05/2005