The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Hemofreeze-bag.
| Device ID | K801082 |
| 510k Number | K801082 |
| Device Name: | GAMBRO HEMOFREEZE-BAG |
| Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Applicant | GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSR |
| CFR Regulation Number | 864.9100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-07 |
| Decision Date | 1980-10-31 |