K962016 is an FDA 510(k) clearance for the MEDLINE TITANIUM HEMOCLIPS. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on July 24, 1996, 62 days after receiving the submission on May 23, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K962016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 1996 |
| Decision Date | July 24, 1996 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FZP — Clip, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |