FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
K Number: K051082
·
Decision Nov 8, 2005
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
21
Review Days
195
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Basic Information
- Device Name
- MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
- K Number
- K051082
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtrade Products , Ltd.
- Date Received
- April 27, 2005
- Decision Date
- November 8, 2005
- Product Code
- KMF
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
FDA 510(k)
FDA Class 1
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