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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 K974121
Device Name LUBRICATED BAGGY TACTYLON CONDOM
Applicant
SENSICON CORP.
2595 COMMERCE WAY
VISTA,  CA  92083
Applicant Contact JEFF D GRANT
Correspondent
SENSICON CORP.
2595 COMMERCE WAY
VISTA,  CA  92083
Correspondent Contact JEFF D GRANT
Regulation Number884.5300
Classification Product Code
MOL  
Date Received10/31/1997
Decision Date 01/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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