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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Gastro-Urology Use
510(k) Number K872630
Device Name ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.
Applicant
Hgm, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Applicant Contact DENNIS REIGLE
Correspondent
Hgm, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Correspondent Contact DENNIS REIGLE
Regulation Number878.4810
Classification Product Code
LNK  
Date Received07/06/1987
Decision Date 08/25/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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