K771625 is an FDA 510(k) clearance for the LEININGEO AORTIC PUNCH #310-395 & 397. This device is classified as a Instruments, Surgical, Cardiovascular (Class I - General Controls, product code DWS).
Submitted by J. Jamner Surgical Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1977, 18 days after receiving the submission on August 25, 1977.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4500.
| 510(k) Number | K771625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1977 |
| Decision Date | September 12, 1977 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DWS — Instruments, Surgical, Cardiovascular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4500 |