The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Ophthalmic Cautery #6821-hot-temp #'s.
| Device ID | K833648 |
| 510k Number | K833648 |
| Device Name: | OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S |
| Classification | Apparatus, Electrosurgical |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HAM |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-17 |
| Decision Date | 1983-11-29 |