The following data is part of a premarket notification filed by Medtrade Products Ltd. with the FDA for Chg Antibacterial Foam Dressing, Chg Antibacterial Patch, Chg Antibacterial Foam Patch, Chg Patch, Chg Dressing.
| Device ID | K120930 |
| 510k Number | K120930 |
| Device Name: | CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING |
| 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 | Yes |
| Date Received | 2012-03-27 |
| Decision Date | 2012-10-26 |
| Summary: | summary |