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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pliers, Surgical
510(k) Number K854390
Device Name WIRE CUTTING PLIERS OR LINEMAN'S PLIERS
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
HTC  
Date Received10/31/1985
Decision Date 11/19/1985
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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