MEDTRADE PRODICT'S SOOTHING GEL PATCH
FDA 510(k) clearance K030901 · decided 2004-11-26
Clearance details
- K-number
- K030901
- Device name
- MEDTRADE PRODICT'S SOOTHING GEL PATCH
- Applicant
- Medtrade Products , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-03-24
- Decision date
- 2004-11-26
- Days to decision
- 613 days
- Clearance type
- Traditional
- Product code
- NTC
- Device class
- 1
- Regulation number
- 880.5630
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Cheshire, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.