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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Laser, Neurosurgical, Argon
510(k) Number K870773
Device Name ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER
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
Classification Product Code
LLF  
Date Received02/26/1987
Decision Date 07/10/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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