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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 K904342
Device Name SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A
Applicant
Hgm Medical Laser Systems, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Applicant Contact DENNIS REIGLE
Correspondent
Boston Scientific
100 Boston Scientific Way
Marlborough,  MD  01752
Correspondent Contact Donna M Gardner
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/21/1990
Decision Date 12/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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