The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Needle Holder, Microvascular.
| Device ID | K771859 |
| 510k Number | K771859 |
| Device Name: | NEEDLE HOLDER, MICROVASCULAR |
| Classification | Holder, Needle, Gastroenterologic |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FHQ |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-09-29 |
| Decision Date | 1977-10-04 |