The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Deep Balfour Blade For Wilkinson Retract.
| Device ID | K801611 |
| 510k Number | K801611 |
| Device Name: | DEEP BALFOUR BLADE FOR WILKINSON RETRACT |
| Classification | Retractor |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-15 |
| Decision Date | 1980-08-04 |