The following data is part of a premarket notification filed by Medtrade Products Ltd. with the FDA for Celox Gauze Pro.
| Device ID | K113560 |
| 510k Number | K113560 |
| Device Name: | CELOX GAUZE PRO |
| Classification | Dressing, Wound, Drug |
| Applicant | MEDTRADE PRODUCTS LTD. ELECTRA HOUSE CREWE BUSINESS PARK CREWE Cheshire, GB Cw1 6gl |
| Contact | Claire Ryan |
| Correspondent | Claire Ryan 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 | 2011-12-01 |
| Decision Date | 2012-08-01 |
| Summary: | summary |