The following data is part of a premarket notification filed by Medtrade Products Limited with the FDA for Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni Stat Pro.
| Device ID | K093593 |
| 510k Number | K093593 |
| Device Name: | CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO |
| Classification | Dressing, Wound, Drug |
| Applicant | MEDTRADE PRODUCTS LIMITED ELECTRA HOUSE CREW BUSINESS PARK Crewe, Cheshire, GB Cwi 6gl |
| Contact | Jonathan Ranfield |
| Correspondent | Jonathan Ranfield MEDTRADE PRODUCTS LIMITED ELECTRA HOUSE CREW BUSINESS PARK Crewe, Cheshire, GB Cwi 6gl |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-19 |
| Decision Date | 2010-01-20 |
| Summary: | summary |