K860511 is an FDA 510(k) clearance for the AMPU-PAK. This device is classified as a Container, Frozen Donor Tissue Storage.
Submitted by Ammerman Medical Enterprises, Inc. (Naples, US). The FDA issued a Cleared decision on August 4, 1986, 174 days after receiving the submission on February 11, 1986.
This device falls under the General Hospital FDA review panel.
| 510(k) Number | K860511 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 1986 |
| Decision Date | August 04, 1986 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LPZ — Container, Frozen Donor Tissue Storage |
| Device Class | — |