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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 K910898
FOIA Releasable 510(k) K910898
Device Name SURGICA(TM) H
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 Received03/04/1991
Decision Date 05/31/1991
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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