The following data is part of a premarket notification filed by Janus Biomedical, Inc. with the FDA for Cryobag.
Device ID | K915471 |
510k Number | K915471 |
Device Name: | CRYOBAG |
Classification | Container, Frozen Donor Tissue Storage |
Applicant | JANUS BIOMEDICAL, INC. 2525 HARTFORD RD. Austin, TX 78703 |
Contact | Richard Martin |
Correspondent | Richard Martin JANUS BIOMEDICAL, INC. 2525 HARTFORD RD. Austin, TX 78703 |
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 | 1991-12-06 |
Decision Date | 1994-03-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CRYOBAG 78026674 not registered Dead/Abandoned |
OriGen Biomedical 2000-09-19 |