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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drape, surgical
510(k) Number K914929
Device Name LACERATION TRAY
Applicant
WESTMARK HOSPITAL SUPPLIES
1253 ramona se
grand rapids,  MI  49507
Applicant Contact marjorie l schmidt
Correspondent
WESTMARK HOSPITAL SUPPLIES
1253 ramona se
grand rapids,  MI  49507
Correspondent Contact marjorie l schmidt
Regulation Number878.4370
Classification Product Code
KKX  
Date Received11/04/1991
Decision Date 01/31/1992
Decision substantially equivalent - kit with drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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