The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Accessus Dry Storage Package Sterile Comp Storage.
| Device ID | K861761 |
| 510k Number | K861761 |
| Device Name: | ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE |
| Classification | Container, Frozen Donor Tissue Storage |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | John Brda |
| Correspondent | John Brda TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Product Code | LPZ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-06 |
| Decision Date | 1986-08-28 |