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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 K862580
Device Name NEPHROSTOMY DRAINAGE KIT (A-150)
Applicant
Advanced Clinical Products, Inc.
10817 Trade Rd.
Richmond,  VA  23236
Applicant Contact GENE L MRAVA
Correspondent
Advanced Clinical Products, Inc.
10817 Trade Rd.
Richmond,  VA  23236
Correspondent Contact GENE L MRAVA
Regulation Number876.5250
Classification Product Code
KNX  
Date Received07/07/1986
Decision Date 09/23/1986
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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