The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Platelet Separation/concentration System.
Device ID | BK040068 |
510k Number | BK040068 |
Device Name: | Platelet Separation/Concentration System |
Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
Applicant | Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 US |
Product Code | JQC |
CFR Regulation Number | 862.2050 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-08-31 |
Decision Date | 2004-11-09 |