510(k) K002845
K002845 is an FDA 510(k) premarket notification submitted by Paragon Vision Sciences for the device "PAFLUFOCON C AND E DAILY CONTACT LENS". The FDA issued a decision of Substantially Equivalent on December 8, 2000. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Paragon Vision Sciences has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 2000
- Date Received
- September 12, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Contact (Other Material) - Daily
- Device Class
- Class II
- Regulation Number
- 886.5916
- Review Panel
- OP
- Submission Type