The following data is part of a premarket notification filed by Intramed Laboratories, Inc. with the FDA for Titanium Hemostatic Clip.
| Device ID | K953258 |
| 510k Number | K953258 |
| Device Name: | TITANIUM HEMOSTATIC CLIP |
| Classification | Clip, Implantable |
| Applicant | INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Contact | R. Alden Kay |
| Correspondent | R. Alden Kay INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-12 |
| Decision Date | 1996-01-05 |