K853663 is an FDA 510(k) clearance for the ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR. This device is classified as a Container, Frozen Donor Tissue Storage.
Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on April 9, 1986, 218 days after receiving the submission on September 3, 1985.
This device falls under the General Hospital FDA review panel.
| 510(k) Number | K853663 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1985 |
| Decision Date | April 09, 1986 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LPZ — Container, Frozen Donor Tissue Storage |
| Device Class | — |