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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 K981952
Device Name COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASER
Applicant
Instruments For Medicine and Diagnostics
3959 W. 1820 S.
Salt Lake City,  UT  84104
Applicant Contact WILLIAM J MCMAHAN
Correspondent
Instruments For Medicine and Diagnostics
3959 W. 1820 S.
Salt Lake City,  UT  84104
Correspondent Contact WILLIAM J MCMAHAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/03/1998
Decision Date 09/01/1998
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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