The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Swan Knife Needle 1.5mm Cat # 1170.
| Device ID | K791981 |
| 510k Number | K791981 |
| Device Name: | SWAN KNIFE NEEDLE 1.5MM CAT # 1170 |
| Classification | Knife, Ophthalmic |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HNN |
| 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 |