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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 K101561
FOIA Releasable 510(k) K101561
Device Name TX1 TISSUE REMOVAL SYSTEM
Applicant
American Optisurgical, Inc.
25501 Arctic Ocean
Lake Forest,  CA  92630
Applicant Contact DAVID SALZBERG
Correspondent
American Optisurgical, Inc.
25501 Arctic Ocean
Lake Forest,  CA  92630
Correspondent Contact DAVID SALZBERG
Classification Product Code
LFL  
Subsequent Product Code
GEI  
Date Received06/04/2010
Decision Date 08/27/2010
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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