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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 K880814
Device Name DX101 ULTRASONIC SURGICAL SYSTEM
Applicant
Niic U.S.A., Inc.
460 Seaport Ct., Suite 101
Redwood City,  CA  94063
Applicant Contact NOBY H MASUO
Correspondent
Niic U.S.A., Inc.
460 Seaport Ct., Suite 101
Redwood City,  CA  94063
Correspondent Contact NOBY H MASUO
Classification Product Code
LFL  
Date Received02/17/1988
Decision Date 04/13/1988
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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