FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sensor Medical Family of Vitrectomy Lenses and Products
K Number: K142715
·
Decision Dec 16, 2014
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
40
Applicant Total
3
Review Days
85
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Basic Information
- Device Name
- Sensor Medical Family of Vitrectomy Lenses and Products
- K Number
- K142715
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1385
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sensor Medical Technology, LLC
- Date Received
- September 22, 2014
- Decision Date
- December 16, 2014
- Product Code
- HJK
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | FDA class 2 | Ophthalmic |
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