K030901 is an FDA 510(k) clearance for the MEDTRADE PRODICT'S SOOTHING GEL PATCH. This device is classified as a Nursing Pad, Hydrogel (Class I - General Controls, product code NTC).
Submitted by Medtrade Products , Ltd. (Cheshire, GB). The FDA issued a Cleared decision on November 26, 2004, 613 days after receiving the submission on March 24, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5630.
| 510(k) Number | K030901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2003 |
| Decision Date | November 26, 2004 |
| Days to Decision | 613 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | NTC — Nursing Pad, Hydrogel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5630 |