The following data is part of a premarket notification filed by Medtrade Products Ltd. with the FDA for Medtrade Products Celox Trauma Gauze.
| Device ID | K091795 |
| 510k Number | K091795 |
| Device Name: | MEDTRADE PRODUCTS CELOX TRAUMA GAUZE |
| Classification | Dressing, Wound, Drug |
| Applicant | MEDTRADE PRODUCTS LTD. ELECTRA HOUSE CREWE BUSINESS PARK Crewe, Cheshire, GB Cw1 6gl |
| Contact | Jonathan Ranfield |
| Correspondent | Jonathan Ranfield MEDTRADE PRODUCTS LTD. ELECTRA HOUSE CREWE BUSINESS PARK Crewe, Cheshire, 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 | 2009-06-17 |
| Decision Date | 2009-11-20 |
| Summary: | summary |