FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Endocular Viewing Lenses and Silicone Ring
K Number: K173944
·
Decision Oct 25, 2018
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
40
Applicant Total
4
Review Days
303
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Basic Information
- Device Name
- Endocular Viewing Lenses and Silicone Ring
- K Number
- K173944
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1385
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phakos
- Date Received
- December 26, 2017
- Decision Date
- October 25, 2018
- 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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