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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
Predetermined Change
Control Plan Authorized		 No
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