Submission Details
| 510(k) Number | K861761 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 06, 1986 |
| Decision Date | August 28, 1986 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
K861761 is an FDA 510(k) clearance for the ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE, a Container, Frozen Donor Tissue Storage, submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on August 28, 1986, 114 days after receiving the submission on May 6, 1986. This device falls under the General Hospital review panel.
| 510(k) Number | K861761 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 06, 1986 |
| Decision Date | August 28, 1986 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LPZ — Container, Frozen Donor Tissue Storage |
| Device Class | — |