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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bag, Urine Collection, Leg, For External Use, Sterile
510(k) Number K896129
Device Name URINARY LEG BAG
Applicant
Cypress Medical Products, Ltd.
1202 S. Rte. 31
Mc Henry,  IL  60050
Applicant Contact VARUN SONI
Correspondent
Cypress Medical Products, Ltd.
1202 S. Rte. 31
Mc Henry,  IL  60050
Correspondent Contact VARUN SONI
Regulation Number876.5250
Classification Product Code
FAQ  
Date Received10/23/1989
Decision Date 04/16/1990
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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