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510(k) K934172

ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS by Acro-Poly, Inc. — Product Code GEY

K934172 is an FDA 510(k) premarket notification submitted by Acro-Poly, Inc. for the device "ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS". The FDA issued a decision of Substantially Equivalent on October 27, 1993. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1993
Date Received
August 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Ac-Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

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FDA data resources