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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 K862227
Device Name MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN
Applicant
Hgm, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Applicant Contact LANDUCCI, M.D.
Correspondent
Hgm, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Correspondent Contact LANDUCCI, M.D.
Regulation Number884.4550
Classification Product Code
HHR  
Date Received06/11/1986
Decision Date 08/19/1986
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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