K953258 is an FDA 510(k) clearance for the TITANIUM HEMOSTATIC CLIP, a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by Intramed Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on January 5, 1996, 177 days after receiving the submission on July 12, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K953258 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 12, 1995 |
| Decision Date | January 05, 1996 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZP — Clip, Implantable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4300 |