The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Automatic Hemoclip Applier, 527700.
| Device ID | K810324 |
| 510k Number | K810324 |
| Device Name: | AUTOMATIC HEMOCLIP APPLIER, 527700 |
| Classification | Staple, Implantable |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-06 |
| Decision Date | 1981-03-20 |