K964470 is an FDA 510(k) clearance for the APPLIED MEDICAL CLIP APPLIER. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on January 22, 1997, 76 days after receiving the submission on November 7, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K964470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 1996 |
| Decision Date | January 22, 1997 |
| Days to Decision | 76 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 |