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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Incontinence, Urosheath Type, Sterile
510(k) Number K903715
Device Name CONDOM SEAL
Applicant
Mark Sullivan, M.D., P.C.
26732 Crown Valley Pkwy.
Suite 111
Mission Viejo,  CA  92691
Applicant Contact MARK SULLIVAN
Correspondent
Mark Sullivan, M.D., P.C.
26732 Crown Valley Pkwy.
Suite 111
Mission Viejo,  CA  92691
Correspondent Contact MARK SULLIVAN
Regulation Number876.5250
Classification Product Code
EXJ  
Date Received08/14/1990
Decision Date 01/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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