The following data is part of a premarket notification filed by Vulcon Technologies with the FDA for Microspin 24.
Device ID | K953519 |
510k Number | K953519 |
Device Name: | MICROSPIN 24 |
Classification | Instrument, Hematocrit, Automated |
Applicant | VULCON TECHNOLOGIES 718 MAIN ST. Grandview, MO 64030 |
Contact | Jeff Hestand |
Correspondent | Jeff Hestand VULCON TECHNOLOGIES 718 MAIN ST. Grandview, MO 64030 |
Product Code | GKF |
CFR Regulation Number | 864.5600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-27 |
Decision Date | 1995-11-03 |