FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Cavilon Advanced High Endurance Skin Protectant
K Number: K153571
·
Decision Aug 23, 2016
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
21
Review Days
252
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Basic Information
- Device Name
- Cavilon Advanced High Endurance Skin Protectant
- K Number
- K153571
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Healthcare
- Date Received
- December 15, 2015
- Decision Date
- August 23, 2016
- 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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MARATHON NO STING LIQUID SKIN PROTECTANT
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