The following data is part of a premarket notification filed by Medtrade Products Ltd. with the FDA for Medtrade Products Celox Hemostatic Granules On Sheet.
| Device ID | K080097 |
| 510k Number | K080097 |
| Device Name: | MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET |
| 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 | No |
| Date Received | 2008-01-14 |
| Decision Date | 2008-07-09 |
| Summary: | summary |