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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Surgical, Gynecologic
510(k) Number K881507
Device Name ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES
Applicant
Hgm Medical Laser Systems, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Applicant Contact R MCARTHUR
Correspondent
Hgm Medical Laser Systems, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Correspondent Contact R MCARTHUR
Regulation Number884.4550
Classification Product Code
HHR  
Date Received04/11/1988
Decision Date 04/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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