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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K855143
Device Name ANGIOMED EXCHANGE DRAINAGE CATHETER SETS
Applicant
ANGIOMED U.S., INC.
4081 EAST LA PALMA AVE.,
SUITE E
ANAHEIM,  CA  92807
Applicant Contact RICHARD P MOHR
Correspondent
ANGIOMED U.S., INC.
4081 EAST LA PALMA AVE.,
SUITE E
ANAHEIM,  CA  92807
Correspondent Contact RICHARD P MOHR
Regulation Number876.5130
Classification Product Code
KOD  
Date Received12/26/1985
Decision Date 03/11/1986
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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