The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Fleischman-swartz Endo-ocular Probe (sterile).
| Device ID | K860358 |
| 510k Number | K860358 |
| Device Name: | FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE) |
| Classification | Laser, Ophthalmic |
| Applicant | HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Greg Mcarthur |
| Correspondent | Greg Mcarthur 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 | 1986-01-30 |
| Decision Date | 1986-03-21 |