E-25 KRYPTON ION LASER (SURGICA K5)

Powered Laser Surgical Instrument

HGM, INC.

The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for E-25 Krypton Ion Laser (surgica K5).

Pre-market Notification Details

Device IDK930543
510k NumberK930543
Device Name:E-25 KRYPTON ION LASER (SURGICA K5)
ClassificationPowered Laser Surgical Instrument
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 CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-02-02
Decision Date1993-06-22

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