The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Hem-o-lok(tm).
| Device ID | K902108 |
| 510k Number | K902108 |
| Device Name: | HEM-O-LOK(TM) |
| Classification | Clip, Implantable |
| Applicant | EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Contact | Glenn M Mattei |
| Correspondent | Glenn M Mattei EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-08 |
| Decision Date | 1990-08-06 |