The following data is part of a premarket notification filed by Vitalitec Int'l., Inc. with the FDA for Titanium Hemostatic Clip.
| Device ID | K981645 |
| 510k Number | K981645 |
| Device Name: | TITANIUM HEMOSTATIC CLIP |
| Classification | Clip, Implantable |
| Applicant | VITALITEC INT'L., INC. 15 CASWELL LN. 3RD FLOOR Plymouth, MA 02360 |
| Contact | Ellen Henke-knupp |
| Correspondent | Ellen Henke-knupp VITALITEC INT'L., INC. 15 CASWELL LN. 3RD FLOOR Plymouth, MA 02360 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-08 |
| Decision Date | 1998-10-13 |
| Summary: | summary |