The following data is part of a premarket notification filed by Exeter Instruments, Inc. with the FDA for Exeter Operating Loupe.
| Device ID | K810817 |
| 510k Number | K810817 |
| Device Name: | EXETER OPERATING LOUPE |
| Classification | Spectacle, Operating (loupe), Ophthalmic |
| Applicant | EXETER INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HOH |
| CFR Regulation Number | 886.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-24 |
| Decision Date | 1981-04-23 |