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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 K854480
Device Name URINARY DRAINAGE BAG
Applicant
The West Co., Inc.
Cemetery & Oliver St.
Jersey Shore,  PA  17740
Applicant Contact GEORGE ALBRECHT
Correspondent
The West Co., Inc.
Cemetery & Oliver St.
Jersey Shore,  PA  17740
Correspondent Contact GEORGE ALBRECHT
Regulation Number876.5250
Classification Product Code
KNX  
Date Received11/07/1985
Decision Date 11/19/1985
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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