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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 K921300
FOIA Releasable 510(k) K921300
Device Name MODEL PC ARGON ION LASER
Applicant
Hgm Medical Laser Systems, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Applicant Contact GREGORY MCARTHUR
Correspondent
Hgm Medical Laser Systems, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Correspondent Contact GREGORY MCARTHUR
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/18/1992
Decision Date 10/06/1992
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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