FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Operio
K Number: K153498
·
Decision Jul 20, 2016
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
5
Applicant Total
3
Review Days
226
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Basic Information
- Device Name
- Operio
- K Number
- K153498
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5070
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Toul Meditech AB
- Date Received
- December 7, 2015
- Decision Date
- July 20, 2016
- Product Code
- ORC
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| ORC | Air Filter Portable Apparatus | FDA class 2 | General, Plastic Surgery |
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