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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 K880034
Device Name CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT
Applicant
Lin-Mark, Inc.
5720 Crenshaw Suite E
P.O. Box 21424
Tampa,  FL  33622
Applicant Contact LOUIS G MARKS
Correspondent
Lin-Mark, Inc.
5720 Crenshaw Suite E
P.O. Box 21424
Tampa,  FL  33622
Correspondent Contact LOUIS G MARKS
Regulation Number876.5250
Classification Product Code
KNX  
Date Received01/05/1988
Decision Date 03/02/1988
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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