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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 K970667
Device Name NUVO-LASE 660 LASER SYSTEM
Applicant
American Laser Medical
1832 S. 3850 W.
Salt Lake City,  UT  84104
Applicant Contact DANIEL HOEFER
Correspondent
American Laser Medical
1832 S. 3850 W.
Salt Lake City,  UT  84104
Correspondent Contact DANIEL HOEFER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/24/1997
Decision Date 05/13/1997
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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