The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for Blood Freezing Bag.
| Device ID | K810500 |
| 510k Number | K810500 |
| Device Name: | BLOOD FREEZING BAG |
| Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Applicant | DELMED, INC. (SENT TO BUREAU OF DRUGS) |
| Product Code | KSR |
| CFR Regulation Number | 864.9100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-24 |
| Decision Date | 1981-09-23 |