Processing Systems For Frozen Blood
System, Processing For Frozen Blood
Haemonetics Corporation
The following data is part of a premarket notification filed by Haemonetics Corporation with the FDA for Processing Systems For Frozen Blood.
Pre-market Notification Details
| Device ID | BK040077 |
| 510k Number | BK040077 |
| Device Name: | Processing Systems For Frozen Blood |
| Classification | System, Processing For Frozen Blood |
| Applicant | Haemonetics Corporation 400 Wood Road Braintree, MA 02184 |
| Product Code | KSW |
| CFR Regulation Number | 864.9145 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-13 |
| Decision Date | 2004-12-21 |
NIH GUDID Devices
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.