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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K896213
Device Name Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET
Applicant
Westmark, Sterile Packing Systems, Inc. (Sps)
1253 Ramona St. SE
Grand Rapids,  MI  49507
Applicant Contact SURY SHONEY
Correspondent
Westmark, Sterile Packing Systems, Inc. (Sps)
1253 Ramona St. SE
Grand Rapids,  MI  49507
Correspondent Contact SURY SHONEY
Regulation Number876.5130
Classification Product Code
KOD  
Date Received10/26/1989
Decision Date 01/18/1990
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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