The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Hemoclip X-20 Automatic Hemoclip Ligating Applier.
| Device ID | K844836 |
| 510k Number | K844836 |
| Device Name: | HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER |
| Classification | Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp |
| Applicant | EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Contact | Jeffrey Green |
| Correspondent | Jeffrey Green EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Product Code | GWD |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-12 |
| Decision Date | 1985-01-23 |