The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Trephine Blades-various Models.
| Device ID | K823901 |
| 510k Number | K823901 |
| Device Name: | TREPHINE BLADES-VARIOUS MODELS |
| Classification | Engine, Trephine, Accessories, Ac-powered |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HRG |
| CFR Regulation Number | 886.4070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-30 |
| Decision Date | 1983-01-17 |