Cleared Traditional

ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE

K861761 · Travenol Laboratories, S.A. · General Hospital
Aug 1986
Decision
114d
Days
Risk

About This 510(k) Submission

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.

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

Device Classification

Product Code LPZ — Container, Frozen Donor Tissue Storage
Device Class