The following data is part of a premarket notification filed by Origen Biomedical, Inc. with the FDA for Cryobag, Model Cb.
| Device ID | K021702 |
| 510k Number | K021702 |
| Device Name: | CRYOBAG, MODEL CB |
| Classification | Container, Frozen Donor Tissue Storage |
| Applicant | ORIGEN BIOMEDICAL, INC. 9709-A BECK CIRCLE Austin, TX 78758 |
| Contact | Richard Martin |
| Correspondent | Richard Martin ORIGEN BIOMEDICAL, INC. 9709-A BECK CIRCLE Austin, TX 78758 |
| 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 | 2002-05-23 |
| Decision Date | 2002-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816203023630 | K021702 | 000 |
| 20816203023623 | K021702 | 000 |
| 20816203023616 | K021702 | 000 |
| 20816203023609 | K021702 | 000 |
| 10816203023596 | K021702 | 000 |
| 10816203020700 | K021702 | 000 |
| 10816203020694 | K021702 | 000 |
| 10816203020687 | K021702 | 000 |
| 10816203020656 | K021702 | 000 |