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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, ultrasonic surgical
510(k) Number K021989
Device Name SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
Applicant
INTEGRA NEUROSCIENCES
5955 PACIFIC CENTER BLVD.
SAN DIEGO,  CA  92121
Applicant Contact NANCY MATHEWSON
Correspondent
INTEGRA NEUROSCIENCES
5955 PACIFIC CENTER BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact NANCY MATHEWSON
Classification Product Code
LFL  
Date Received06/18/2002
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
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