The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Hgm Illuminating Imaging Endocular Probe.
| Device ID | K931784 |
| 510k Number | K931784 |
| Device Name: | HGM ILLUMINATING IMAGING ENDOCULAR 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 | 1993-04-09 |
| Decision Date | 1994-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290109140800 | K931784 | 000 |
| 17290109140794 | K931784 | 000 |
| 17290109140787 | K931784 | 000 |
| 17290109140770 | K931784 | 000 |