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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name chisel (osteotome)
510(k) Number K872092
Device Name OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5
Applicant
MILITARY ENGINEERING, INC.
P.O. BOX J 2135 WESTERN
AVENUE
PLYMOUTH,  IN  46563
Applicant Contact ROBERT W FRANCIS
Correspondent
MILITARY ENGINEERING, INC.
P.O. BOX J 2135 WESTERN
AVENUE
PLYMOUTH,  IN  46563
Correspondent Contact ROBERT W FRANCIS
Regulation Number878.4820
Classification Product Code
KDG  
Date Received06/01/1987
Decision Date 06/23/1987
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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