510(k) K993487
K993487 is an FDA 510(k) premarket notification submitted by Paragon Vision Sciences for the device "PARAGON LENS VIAL". The FDA issued a decision of Substantially Equivalent on December 22, 1999. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Paragon Vision Sciences has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1999
- Date Received
- October 15, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Case, Contact Lens
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type