CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM


Device Classification Name

instrument, ultrasonic surgical

510(k) Number K081459
Device Name CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM
Applicant
INTEGRA RADIONICS, INC.
22 terry avenue
burlington, 
MA 
01803

Applicant Contact kevin j o’connell
Correspondent
INTEGRA RADIONICS, INC.
22 terry avenue
burlington, 
MA 
01803

Correspodent Contact kevin j o’connell
Classification Product Code
LFL  
Date Received 05/23/2008
Decision Date 08/13/2008
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls