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 |