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510(k) K890787

Device
O-020 LASER INDIRECT OPHTHALMOSCOPE
Applicant
HGM MEDICAL LASER SYSTEMS, INC.
510(k) number
K890787
Product code
HGF  
Decision
Substantially Equivalent (SESE)
Decision date
1989-03-24
Date received
1989-02-15
Regulation
884.5070
Classification name
Source, Abortion Unit, Vacuum
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BILL PAPWORTH
Address
3959 W. 1820 S. Salt Lake City UT US 84104 84104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HGF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945179BOTTLE COLLECTION SETMedgyn Products, Inc.1995-01-26
K905115BIOVISION ENDOCULAR PROBEDouglas James Donaldson Compliance Services1991-02-11
K904248MODEL GLASE 210 HOLMIUM LASER SYSTEMCharles L. Rose and Co., Inc.1990-12-14

Legacy Summary#

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FDA Review#

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