HGM ILLUMINATING IMAGING ENDOCULAR PROBE

Laser, Ophthalmic

HGM, INC.

The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Hgm Illuminating Imaging Endocular Probe.

Pre-market Notification Details

Device IDK931784
510k NumberK931784
Device Name:HGM ILLUMINATING IMAGING ENDOCULAR PROBE
ClassificationLaser, Ophthalmic
Applicant HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City,  UT  84104
ContactJoseph G Lambert
CorrespondentJoseph G Lambert
HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City,  UT  84104
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-09
Decision Date1994-03-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290109140800 K931784 000
17290109140794 K931784 000
17290109140787 K931784 000
17290109140770 K931784 000

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