The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Day Ear Hook.
| Device ID | K772390 |
| 510k Number | K772390 |
| Device Name: | DAY EAR HOOK |
| Classification | Hook, Microsurgical Ear |
| Applicant | EDWARD WECK, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JYL |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-27 |
| Decision Date | 1978-01-17 |