The following data is part of a premarket notification filed by Medtrade Products Ltd. with the FDA for Celox Trauma Gauze Ag, Celox Hemostatic Antibacterial Trauma Gauze, Omni-stat Trauma Gauze Ag, Omni-stat Hemostatic Anti.
| Device ID | K102965 |
| 510k Number | K102965 |
| Device Name: | CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI |
| Classification | Dressing, Wound, Drug |
| Applicant | MEDTRADE PRODUCTS LTD. ELECTRA HOUSE CREWE BUSINESS PARK CREWE Cheshire, GB Cw1 6gl |
| Contact | Jonathan D Ranfield |
| Correspondent | Jonathan D 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 | Yes |
| Date Received | 2010-10-05 |
| Decision Date | 2010-12-08 |
| Summary: | summary |