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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K971539
Device Name NOVATIP FAMILY OF LASER HANDPIECE TIPS
Applicant
Xanova Corp.
15018 NE 177th Dr.
Woodinville,  WA  98072
Applicant Contact MICHAEL LEVY
Correspondent
Xanova Corp.
15018 NE 177th Dr.
Woodinville,  WA  98072
Correspondent Contact MICHAEL LEVY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/28/1997
Decision Date 06/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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