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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Surgical Instrument, Ac-Powered
510(k) Number K934172
Device Name ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS
Applicant
Acro-Poly, Inc.
12155 Magnolia Ave.
Suite 8-C
Riverside,  CA  92503
Applicant Contact OTTO R BUTSCH
Correspondent
Acro-Poly, Inc.
12155 Magnolia Ave.
Suite 8-C
Riverside,  CA  92503
Correspondent Contact OTTO R BUTSCH
Regulation Number878.4820
Classification Product Code
GEY  
Date Received08/27/1993
Decision Date 10/27/1993
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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