FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
K Number: K050623
·
Decision Mar 28, 2005
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
40
Applicant Total
4
Review Days
18
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Basic Information
- Device Name
- VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
- K Number
- K050623
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.1385
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Volk Optical, Inc.
- Date Received
- March 10, 2005
- Decision Date
- March 28, 2005
- 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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