510(k) K961243
K961243 is an FDA 510(k) premarket notification submitted by Surgical Design Corp. for the device "OCUSYSTEM ART ADVANTAGE". The FDA issued a decision of Substantially Equivalent on July 10, 1996. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Surgical Design Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1996
- Date Received
- April 1, 1996
- 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