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


Device Classification Name

instrument, ultrasonic surgical

510(k) Number K021929
Device Name AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
Original Applicant
AXYA MEDICAL, INC.
100 cummings center
suite 444c
beverly, 
MA 
01915

Original Contact howard l schrayer
Classification Product Code
LFL  
Date Received 06/12/2002
Decision Date 09/10/2002
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No