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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
510(k) Number K896212
Device Name URETHRAL CATHETERIZATION TRAYS
Applicant
WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
1253 RAMONA ST. S.E.
GRAND RAPIDS,  MI  49507
Applicant Contact SURY SHONEY
Correspondent
WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
1253 RAMONA ST. S.E.
GRAND RAPIDS,  MI  49507
Correspondent Contact SURY SHONEY
Regulation Number876.5130
Classification Product Code
FCM  
Date Received10/26/1989
Decision Date 01/24/1990
Decision Substantially Equivalent - With Drug (SESD)
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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