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 | BK840010 |
510k Number | BK840010 |
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 | 1984-05-16 |
Decision Date | 1984-08-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30887691312381 | BK840010 | 0 |
30887691002879 | BK840010 | 0 |
30887691002855 | BK840010 | 0 |
30887691002848 | BK840010 | 0 |