The following data is part of a premarket notification filed by Medtrade Products Ltd. with the FDA for Medtrade Product's Antiseptic Barrier Hydrogel Dressings.
| Device ID | K022587 |
| 510k Number | K022587 |
| Device Name: | MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| 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 | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2002-08-05 |
| Decision Date | 2003-08-22 |
| Summary: | summary |