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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Abortion Unit, Vacuum
510(k) Number K890787
Device Name O-020 LASER INDIRECT OPHTHALMOSCOPE
Applicant
Hgm Medical Laser Systems, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Applicant Contact BILL PAPWORTH
Correspondent
Hgm Medical Laser Systems, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Correspondent Contact BILL PAPWORTH
Regulation Number884.5070
Classification Product Code
HGF  
Date Received02/15/1989
Decision Date 03/24/1989
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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