510(k) K834453
K834453 is an FDA 510(k) premarket notification submitted by Fibra Sonics, Inc. for the device "PHACO FRAGMENTOR GT-1". The FDA issued a decision of Substantially Equivalent on March 16, 1984. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Fibra Sonics, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1984
- Date Received
- December 19, 1983
- 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