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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 K861953
Device Name PARALLEL ACTION PLIERS
Applicant
MED-TOOL, INC.
12434 MATTHEWS LN.
ST. LOUIS,  MO  63127
Applicant Contact MAYERIK, JR
Correspondent
MED-TOOL, INC.
12434 MATTHEWS LN.
ST. LOUIS,  MO  63127
Correspondent Contact MAYERIK, JR
Regulation Number878.4800
Classification Product Code
HTC  
Date Received05/20/1986
Decision Date 06/06/1986
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
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