The following data is part of a premarket notification filed by Terumo Corporation with the FDA for Transfer Sets.
Device ID | BK860012 |
510k Number | BK860012 |
Device Name: | Transfer Sets |
Classification | Set, Transfer (blood/plasma) |
Applicant | Terumo Corporation 2805 East Ana Street Compton, CA 90221 |
Product Code | KSB |
CFR Regulation Number | 864.9875 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-06 |
Decision Date | 1990-05-16 |