510(k) K082799
K082799 is an FDA 510(k) premarket notification submitted by Paragon Vision Sciences for the device "HDS HI 1.54". The FDA issued a decision of Substantially Equivalent on January 27, 2009. 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
- January 27, 2009
- Date Received
- September 23, 2008
- 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