FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS
K Number: K052606
·
Decision Dec 15, 2005
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
472
Applicant Total
1
Review Days
84
Basic Information
- Device Name
- MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS
- K Number
- K052606
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MARIETTA VISION
- Date Received
- September 22, 2005
- Decision Date
- December 15, 2005
- Product Code
- LPL
- 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 |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | FDA class 2 | Ophthalmic |
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