The following data is part of a premarket notification filed by S.p.k. Technology, Inc. with the FDA for Atrauclip (titanium Hemostatic Clip).
| Device ID | K896997 |
| 510k Number | K896997 |
| Device Name: | ATRAUCLIP (TITANIUM HEMOSTATIC CLIP) |
| Classification | Clip, Implantable |
| Applicant | S.P.K. TECHNOLOGY, INC. 321 REGATTA WAY Seal Beach, CA 90740 |
| Contact | John J Malloy |
| Correspondent | John J Malloy S.P.K. TECHNOLOGY, INC. 321 REGATTA WAY Seal Beach, CA 90740 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-12 |
| Decision Date | 1990-02-13 |