510(k) K030901
- Device
- MEDTRADE PRODICT'S SOOTHING GEL PATCH
- Applicant
- MEDTRADE PRODUCTS LTD.
- 510(k) number
- K030901
- Product code
- NTC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-11-26
- Date received
- 2003-03-24
- Regulation
- 880.5630
- Classification name
- Nursing Pad, Hydrogel
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JONATHAN RANFIELD
- Address
- Electra House Crewe Business Park Crewe Cheshire GB CW1 6GL CW1 6GL
FDA Registration Numbers#
- 3005630901
- 3010256218
- 3013445151
- 3017299798
- 1219103
- 3012759464
- 3017299525
- 3027605322
- 3002807310
- 3005023997
- 3030726486
- 3005951403
- 3005031124
- 1419937
- 3008386507
- 3032172199
- 3015397169
- 3008808560
- 3010183315
- 3007663067
- 3011553249
- 3010132111
- 3036893546
- 3030158784
- 3012309743
- 3009655869
- 9680731
- 9710641
- 3015172365
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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