510(k) K133562
K133562 is an FDA 510(k) premarket notification submitted by Oertli Instrumente AG for the device "CATARHEX 3". The FDA issued a decision of Substantially Equivalent on August 12, 2014. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Oertli Instrumente AG has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2014
- Date Received
- November 20, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Phacofragmentation
- Device Class
- Class II
- Regulation Number
- 886.4670
- Review Panel
- OP
- Submission Type