510(k) K902798
K902798 is an FDA 510(k) premarket notification submitted by Alcon Surgical, Inc. for the device "AUTOMATED HYDROSONICS(TM)". The FDA issued a decision of Substantially Equivalent on August 28, 1990. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Alcon Surgical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 1990
- Date Received
- June 27, 1990
- 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