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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Suprapubic (And Accessories)
510(k) Number K863386
Device Name VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS
Applicant
Angiomed U.S., Inc.
4081 E. La Palma Ave.,
Suite E
Anaheim,  CA  92807
Applicant Contact RICHARD P MOHR
Correspondent
Angiomed U.S., Inc.
4081 E. La Palma Ave.,
Suite E
Anaheim,  CA  92807
Correspondent Contact RICHARD P MOHR
Regulation Number876.5090
Classification Product Code
KOB  
Date Received09/03/1986
Decision Date 10/24/1986
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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