The following data is part of a premarket notification filed by Futuremed with the FDA for Transfer Sets.
Device ID | BK940055 |
510k Number | BK940055 |
Device Name: | Transfer Sets |
Classification | Set, Transfer (blood/plasma) |
Applicant | Futuremed 2076 Deer Park Avenue Deer Park, NY 11729 |
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 | 1994-09-23 |
Decision Date | 1994-12-27 |