510(k) K033656
K033656 is an FDA 510(k) premarket notification submitted by Sauflon Pharmaceuticals, Ltd. for the device "SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE". The FDA issued a decision of Substantially Equivalent on February 2, 2004. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Sauflon Pharmaceuticals, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 2004
- Date Received
- November 21, 2003
- 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