FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DORC VITRECTOMY LENSES, MODEL 1284 SERIES
K Number: K033950
·
Decision Feb 20, 2004
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
40
Applicant Total
1
Review Days
60
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Basic Information
- Device Name
- DORC VITRECTOMY LENSES, MODEL 1284 SERIES
- K Number
- K033950
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1385
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dutch Ophthalmic Research Center (D.O.R.C.)
- Date Received
- December 22, 2003
- Decision Date
- February 20, 2004
- 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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