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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
510(k) Number K890465
Device Name CLOSED SYSTEM URINARY DRAINAGE 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
EYZ  
Date Received01/31/1989
Decision Date 05/23/1989
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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