The following data is part of a premarket notification filed by Genesis Bps, Llc with the FDA for Transfer Sets.
Device ID | BK950018 |
510k Number | BK950018 |
Device Name: | Transfer Sets |
Classification | Set, Transfer (blood/plasma) |
Applicant | Genesis BPS, LLC 65 Commerce Way Hackensack, NJ 07601 |
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 | 1995-02-27 |
Decision Date | 1995-11-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00866305000219 | BK950018 | 0 |
10866305000223 | BK950018 | 0 |
10866305000278 | BK950018 | 0 |