The following data is part of a premarket notification filed by Eisner Usa, Inc. with the FDA for Titanium Hemostatic Clip.
| Device ID | K972745 |
| 510k Number | K972745 |
| Device Name: | TITANIUM HEMOSTATIC CLIP |
| Classification | Clip, Hemostatic |
| Applicant | EISNER USA, INC. 15 CASWELL LANE, BOATYARD SQ. Plymouth, MA 02360 |
| Contact | Ellen Henve-unepp |
| Correspondent | Ellen Henve-unepp EISNER USA, INC. 15 CASWELL LANE, BOATYARD SQ. Plymouth, MA 02360 |
| Product Code | MCH |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-23 |
| Decision Date | 1997-10-21 |
| Summary: | summary |