The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for E-25 Krypton Ion Laser (surgica K5).
Device ID | K930543 |
510k Number | K930543 |
Device Name: | E-25 KRYPTON ION LASER (SURGICA K5) |
Classification | Powered Laser Surgical Instrument |
Applicant | HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
Contact | Joseph G Lambert |
Correspondent | Joseph G Lambert HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-02 |
Decision Date | 1993-06-22 |