The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Davis & Geck Ligating Clip Remover.
| Device ID | K953908 |
| 510k Number | K953908 |
| Device Name: | DAVIS & GECK LIGATING CLIP REMOVER |
| Classification | Clip, Implantable |
| Applicant | DAVIS & GECK, INC. ONE CASPER ST. Danbury, CT 06810 |
| Contact | Stephen J Tamsett |
| Correspondent | Stephen J Tamsett DAVIS & GECK, INC. ONE CASPER ST. Danbury, CT 06810 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-21 |
| Decision Date | 1995-11-30 |