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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 K861251
Device Name AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N
Applicant
American Medical Products, Inc.
759 N. Edgewood Ave.
Jacksonville,  FL  32205
Applicant Contact KEITH E WELSS
Correspondent
American Medical Products, Inc.
759 N. Edgewood Ave.
Jacksonville,  FL  32205
Correspondent Contact KEITH E WELSS
Regulation Number876.5250
Classification Product Code
KNX  
Date Received04/02/1986
Decision Date 04/17/1986
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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