The following data is part of a premarket notification filed by Medtrade Products Ltd. with the FDA for Medtrade Prodict's Soothing Gel Patch.
| Device ID | K030901 |
| 510k Number | K030901 |
| Device Name: | MEDTRADE PRODICT'S SOOTHING GEL PATCH |
| Classification | Nursing Pad, Hydrogel |
| Applicant | MEDTRADE PRODUCTS LTD. ELECTRA HOUSE CREWE BUSINESS PARK CREWE Cheshire, GB Cw1 6gl |
| Contact | Jonathan Ranfield |
| Correspondent | Jonathan Ranfield MEDTRADE PRODUCTS LTD. ELECTRA HOUSE CREWE BUSINESS PARK CREWE Cheshire, GB Cw1 6gl |
| Product Code | NTC |
| CFR Regulation Number | 880.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-24 |
| Decision Date | 2004-11-26 |