The following data is part of a premarket notification filed by Medtrade Products Ltd. with the FDA for Celox Rapid Gauze.
| Device ID | K110386 |
| 510k Number | K110386 |
| Device Name: | CELOX RAPID GAUZE |
| Classification | Dressing, Wound, Drug |
| Applicant | MEDTRADE PRODUCTS LTD. ELECTRA HOUSE CREWE BUSINESS PARK Crewe, Cheshire Cw1 6gl, GB Cw1 6gl |
| Contact | Jonathan Ranfield |
| Correspondent | Jonathan Ranfield MEDTRADE PRODUCTS LTD. ELECTRA HOUSE CREWE BUSINESS PARK Crewe, Cheshire Cw1 6gl, GB Cw1 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 | 2011-02-10 |
| Decision Date | 2011-05-10 |
| Summary: | summary |