The following data is part of a premarket notification filed by Haemonetics Manufacturing Inc. with the FDA for Empty Containers For The Collection & Processing Of Blood/blood Components.
| Device ID | BK080003 |
| 510k Number | BK080003 |
| Device Name: | Empty Containers For The Collection & Processing Of Blood/Blood Components |
| Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Applicant | Haemonetics Manufacturing Inc. 400 Wood Road Braintree, MA 02184 |
| Product Code | KSR |
| CFR Regulation Number | 864.9100 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-04 |
| Decision Date | 2008-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30887691310691 | BK080003 | 0 |
| 30887691310684 | BK080003 | 0 |