SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3


Device Classification Name

instrument, ultrasonic surgical

510(k) Number K021989
Device Name SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
Original Applicant
INTEGRA NEUROSCIENCES
5955 pacific center blvd.
san diego, 
CA 
92121

Original Contact nancy mathewson
Classification Product Code
LFL  
Date Received 06/18/2002
Decision Date 09/13/2002
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