510(k) K926512
K926512 is an FDA 510(k) premarket notification submitted by Storz for the device "STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE". The FDA issued a decision of Substantially Equivalent on September 9, 1993. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Storz has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1993
- Date Received
- December 30, 1992
- 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