The following data is part of a premarket notification filed by Medtrade Products Ltd. with the FDA for Medtrade Products Skin Protective Barrier Wipe (sterile And Preserved).
| Device ID | K051082 |
| 510k Number | K051082 |
| Device Name: | MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED) |
| Classification | Bandage, Liquid |
| 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 | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-27 |
| Decision Date | 2005-11-08 |
| Summary: | summary |