The following data is part of a premarket notification filed by Medtrade Products Ltd. with the FDA for Bondiloxs Topical Hemostatic Granules.
| Device ID | K161274 |
| 510k Number | K161274 |
| Device Name: | Bondiloxs Topical Hemostatic Granules |
| Classification | Dressing, Wound, Drug |
| Applicant | MEDTRADE PRODUCTS LTD. ELECTRA HOUSE CREWE BUSINESS PARK Crewe, GB Cw1 6gl |
| Contact | Andrew Whitton |
| Correspondent | Andrew Whitton MEDTRADE PRODUCTS LTD. ELECTRA HOUSE CREWE BUSINESS PARK Crewe, 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 | 2016-05-06 |
| Decision Date | 2017-01-18 |
| Summary: | summary |