510(k) K052074
K052074 is an FDA 510(k) premarket notification submitted by Szabocsik and Associates for the device "JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING,". The FDA issued a decision of Substantially Equivalent on September 1, 2005. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918. Szabocsik and Associates has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2005
- Date Received
- August 1, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Products, Contact Lens Care, Rigid Gas Permeable
- Device Class
- Class II
- Regulation Number
- 886.5918
- Review Panel
- OP
- Submission Type