CytoCore
Instrument, Biopsy
Praxis Medical, LLC
The following data is part of a premarket notification filed by Praxis Medical, Llc with the FDA for Cytocore.
Pre-market Notification Details
| Device ID | K200278 |
| 510k Number | K200278 |
| Device Name: | CytoCore |
| Classification | Instrument, Biopsy |
| Applicant | Praxis Medical, LLC 500 N. Willow Ave. #101 Tampa, FL 33606 |
| Contact | John Fisher |
| Correspondent | Paul Dryden Praxis Medical LLC C/o ProMedic LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-04 |
| Decision Date | 2020-03-31 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003935804 | K200278 | 000 |
| 00860003935866 | K200278 | 000 |
Trademark Results [CytoCore]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CYTOCORE 88052318 not registered Live/Pending |
PRAXIS MEDICAL LLC 2018-07-25 |
 CYTOCORE 78785564 3584729 Dead/Cancelled |
CYTOCORE, INC. 2006-01-05 |
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