The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Micresurgical Tray, Sm.,med., & Lg..
| Device ID | K800367 |
| 510k Number | K800367 |
| Device Name: | MICRESURGICAL TRAY, SM.,MED., & LG. |
| Classification | Tray, Surgical, Instrument |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-20 |
| Decision Date | 1980-03-10 |