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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mallet
510(k) Number K871195
Device Name MALLET, BONE SURGERY, STAINLESS STEEL, 2LB.
Applicant
Military Engineering, Inc.
P.O. Box J 2135 Western
Ave.
Plymouth,  IN  46563
Applicant Contact LEE L HEYDE
Correspondent
Military Engineering, Inc.
P.O. Box J 2135 Western
Ave.
Plymouth,  IN  46563
Correspondent Contact LEE L HEYDE
Regulation Number878.4800
Classification Product Code
HXL  
Date Received03/24/1987
Decision Date 04/06/1987
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
Predetermined Change
Control Plan Authorized		 No
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