The following data is part of a premarket notification filed by Terumo Bct, Inc with the FDA for Transfer Sets.
Device ID | BK170098 |
510k Number | BK170098 |
Device Name: | Transfer Sets |
Classification | Set, Transfer (blood/plasma) |
Applicant | Terumo BCT, Inc 10811 W. Collins Ave. Lakewood, CO 80215 US |
Product Code | KSB |
CFR Regulation Number | 864.9875 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-30 |
Decision Date | 2017-09-29 |