Cleared Traditional

K915471 - CRYOBAG
(FDA 510(k) Clearance)

K915471 · Janus Biomedical, Inc. · General Hospital

Mar 1994

Decision

817d

Days

—

Risk

K915471 is an FDA 510(k) clearance for the CRYOBAG. This device is classified as a Container, Frozen Donor Tissue Storage.

Submitted by Janus Biomedical, Inc. (Austin, US). The FDA issued a Cleared decision on March 2, 1994, 817 days after receiving the submission on December 6, 1991.

This device falls under the General Hospital FDA review panel.

Submission Details

510(k) Number	K915471 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 06, 1991
Decision Date	March 02, 1994
Days to Decision	817 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF