The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Needleholder, Microvasular 5 1/2.
| Device ID | K780154 |
| 510k Number | K780154 |
| Device Name: | NEEDLEHOLDER, MICROVASULAR 5 1/2 |
| Classification | Needle, Ophthalmic Suturing |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HNM |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-30 |
| Decision Date | 1978-03-17 |