FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
K Number: K011893
·
Decision Dec 6, 2001
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
472
Applicant Total
1
Review Days
171
Basic Information
- Device Name
- COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
- K Number
- K011893
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CONTACT COLOR SRL
- Date Received
- June 18, 2001
- Decision Date
- December 6, 2001
- 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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