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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom, Synthetic
510(k) Number K922688
FOIA Releasable 510(k) K922688
Device Name EXTRA PROTECTION POLYURETHANE CONDOM
Applicant
APEX MEDICAL TECHNOLOGIES, INC.
10064 MESA RIDGE CT., #202
SAN DIEGO,  CA  92121
Applicant Contact ALICE A DEPAUL
Correspondent
APEX MEDICAL TECHNOLOGIES, INC.
10064 MESA RIDGE CT., #202
SAN DIEGO,  CA  92121
Correspondent Contact ALICE A DEPAUL
Regulation Number884.5300
Classification Product Code
MOL  
Date Received06/04/1992
Decision Date 05/04/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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