FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
MEDTRADE PRODICT'S SOOTHING GEL PATCH
K Number: K030901
·
Decision Nov 26, 2004
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
0
Applicant Total
21
Review Days
613
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Basic Information
- Device Name
- MEDTRADE PRODICT'S SOOTHING GEL PATCH
- K Number
- K030901
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5630
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medtrade Products , Ltd.
- Date Received
- March 24, 2003
- Decision Date
- November 26, 2004
- Product Code
- NTC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NTC | Nursing Pad, Hydrogel | FDA class 1 | General Hospital |
Other Clearances by Medtrade Products , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K230589 | Celox Rapid X-Ray Gauze | Nov 17, 2023 | Substantially Equivalent |
| K161274 | Bondiloxs Topical Hemostatic Granules | Jan 18, 2017 | Substantially Equivalent |
| K132333 | BONDILOXS TOPICAL HEMOSTATIC DRESSING | Jun 25, 2014 | Substantially Equivalent |
| K120930 | CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING | Oct 26, 2012 | Substantially Equivalent |
| K113560 | CELOX GAUZE PRO | Aug 1, 2012 | Substantially Equivalent |
| K110386 | CELOX RAPID GAUZE | May 10, 2011 | Substantially Equivalent |
| K102965 | CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI | Dec 8, 2010 | Substantially Equivalent |
| K093519 | MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET | Jan 14, 2010 | Substantially Equivalent |
| K091795 | MEDTRADE PRODUCTS CELOX TRAUMA GAUZE | Nov 20, 2009 | Substantially Equivalent |
| K090780 | MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE | Nov 20, 2009 | Substantially Equivalent |