Cleared Traditional

K021702 - CRYOBAG, MODEL CB
(FDA 510(k) Clearance)

K021702 · Origen Biomedical, Inc. · General Hospital

Aug 2002

Decision

75d

Days

—

Risk

K021702 is an FDA 510(k) clearance for the CRYOBAG, MODEL CB. This device is classified as a Container, Frozen Donor Tissue Storage.

Submitted by Origen Biomedical, Inc. (Austin, US). The FDA issued a Cleared decision on August 6, 2002, 75 days after receiving the submission on May 23, 2002.

This device falls under the General Hospital FDA review panel.

Submission Details

510(k) Number	K021702 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 23, 2002
Decision Date	August 06, 2002
Days to Decision	75 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF