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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name File, Surgical, General & Plastic Surgery
510(k) Number K844145
Device Name GENERAL SURGICAL FILES
Applicant
Med-Tool, Inc.
12434 Matthews Ln.
St. Louis,  MO  63127
Applicant Contact JOHN M MAYERIK
Correspondent
Med-Tool, Inc.
12434 Matthews Ln.
St. Louis,  MO  63127
Correspondent Contact JOHN M MAYERIK
Regulation Number878.4800
Classification Product Code
GEO  
Date Received10/23/1984
Decision Date 11/20/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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