MICROAIRE SMARTDRIVE SYSTEM

Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

MICROAIRE SURGICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Microaire Surgical Instruments, Inc. with the FDA for Microaire Smartdrive System.

Pre-market Notification Details

Device IDK955591
510k NumberK955591
Device Name:MICROAIRE SMARTDRIVE SYSTEM
ClassificationInstrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Applicant MICROAIRE SURGICAL INSTRUMENTS, INC. 1641 EDLICH DR. Charlottesville,  VA  22911
ContactMike Fard
CorrespondentMike Fard
MICROAIRE SURGICAL INSTRUMENTS, INC. 1641 EDLICH DR. Charlottesville,  VA  22911
Product CodeHWE  
CFR Regulation Number878.4820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-07
Decision Date1996-01-18

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