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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K902258
Device Name 5 MM IRRIGATION/ASPIRATION FIBER PROBE
Applicant
HGM MEDICAL LASER SYSTEMS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact DENNIS REIGLE
Correspondent
HGM MEDICAL LASER SYSTEMS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Correspondent Contact DENNIS REIGLE
Regulation Number884.1720
Classification Product Code
HET  
Date Received05/21/1990
Decision Date 09/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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