The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Fix. & Lens For. #'s 3510,3512,3248,3795.
| Device ID | K791986 |
| 510k Number | K791986 |
| Device Name: | FIX. & LENS FOR. #'S 3510,3512,3248,3795 |
| Classification | Forceps, Ophthalmic |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HNR |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-25 |
| Decision Date | 1979-10-04 |