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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K861192
Device Name GENTLE BACK, PLASTIC URINARY DRAINAGE BAG
Applicant
Advanced Clinical Products, Inc.
P.O. Box 35684
Richmond,  VA  23235
Applicant Contact GENE L MRAVA
Correspondent
Advanced Clinical Products, Inc.
P.O. Box 35684
Richmond,  VA  23235
Correspondent Contact GENE L MRAVA
Regulation Number876.5250
Classification Product Code
KNX  
Date Received03/31/1986
Decision Date 04/23/1986
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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