The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Hgm Illuminating/aspirating Endoocular Probe.
| Device ID | K931072 |
| 510k Number | K931072 |
| Device Name: | HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE |
| Classification | Transilluminator, Ac-powered |
| 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 | HJM |
| CFR Regulation Number | 886.1945 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-02 |
| Decision Date | 1994-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290109140763 | K931072 | 000 |
| 17290109140756 | K931072 | 000 |