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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 K981262
Device Name CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
Applicant
Valleylab, Inc.
5920 Longbow Dr.
P.O. Box 9015
Boulder,  CO  80301
Applicant Contact JULIE ROSS
Correspondent
Valleylab, Inc.
5920 Longbow Dr.
P.O. Box 9015
Boulder,  CO  80301
Correspondent Contact JULIE ROSS
Classification Product Code
LFL  
Subsequent Product Code
LBK  
Date Received04/07/1998
Decision Date 07/06/1998
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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