AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM

Instrument, Ultrasonic Surgical

AXYA MEDICAL, INC.

The following data is part of a premarket notification filed by Axya Medical, Inc. with the FDA for Axya Medical, Inc, Model 100 Sonic Scalpel Ultrasonic Surgical System.

Pre-market Notification Details

Device IDK021929
510k NumberK021929
Device Name:AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
ClassificationInstrument, Ultrasonic Surgical
Applicant AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly,  MA  01915
ContactHoward L Schrayer
CorrespondentHoward L Schrayer
AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly,  MA  01915
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-12
Decision Date2002-09-10
Summary:summary

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