The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Weck Lx Tm Skin Stapler.
| Device ID | K851258 |
| 510k Number | K851258 |
| Device Name: | WECK LX TM SKIN STAPLER |
| Classification | Stapler, Surgical |
| Applicant | EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Contact | Russell W Boone |
| Correspondent | Russell W Boone EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Product Code | GAG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-28 |
| Decision Date | 1985-06-07 |