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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rasp
510(k) Number K870329
Device Name ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202
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 Number878.4800
Classification Product Code
HTR  
Date Received01/28/1987
Decision Date 02/13/1987
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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