The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Hgm Aspirating Endoocular(tm) Probe.
Device ID | K925663 |
510k Number | K925663 |
Device Name: | HGM ASPIRATING ENDOOCULAR(TM) PROBE |
Classification | Laser, Ophthalmic |
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 | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-10 |
Decision Date | 1993-08-17 |