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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Mill
510(k) Number K861164
Device Name OSTEOMILL BONE GRINDER
Applicant
Biodynamic Technologies, Inc.
727 Twenty-Third St. S.
Arlington,  VA  22202
Applicant Contact KEVIN J DUNLEAVY
Correspondent
Biodynamic Technologies, Inc.
727 Twenty-Third St. S.
Arlington,  VA  22202
Correspondent Contact KEVIN J DUNLEAVY
Regulation Number888.4540
Classification Product Code
LYS  
Date Received03/28/1986
Decision Date 05/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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