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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Drill, Ligament
510(k) Number K880739
Device Name DYONICS DRILL GUIDE/ISOMETER SYSTEM
Applicant
DYONICS, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Applicant Contact KENNETH E CARRIER
Correspondent
DYONICS, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Correspondent Contact KENNETH E CARRIER
Regulation Number878.4820
Classification Product Code
LXI  
Date Received02/24/1988
Decision Date 03/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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