510(k) K980292
K980292 is an FDA 510(k) premarket notification submitted by Alcon Laboratories for the device "CATARACT LIQUEFRACTURE DEVICE". The FDA issued a decision of Substantially Equivalent on May 19, 1998. The device falls under product code MUS (Fluidic, Phacoemulsification/Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Alcon Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 1998
- Date Received
- January 26, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluidic, Phacoemulsification/Phacofragmentation
- Device Class
- Class II
- Regulation Number
- 886.4670
- Review Panel
- OP
- Submission Type