The following data is part of a premarket notification filed by Canyon Diagnostics, Inc. with the FDA for Cantrol Spinal Fluid Control.
Device ID | K854190 |
510k Number | K854190 |
Device Name: | CANTROL SPINAL FLUID CONTROL |
Classification | Total Spinal-fluid, Antigen, Antiserum, Control |
Applicant | CANYON DIAGNOSTICS, INC. 4081 E. LA PALMA AVE., UNIT F Anaheim, CA 92807 |
Contact | Falkowski |
Correspondent | Falkowski CANYON DIAGNOSTICS, INC. 4081 E. LA PALMA AVE., UNIT F Anaheim, CA 92807 |
Product Code | DFI |
CFR Regulation Number | 866.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-10-15 |
Decision Date | 1985-11-25 |