510(k) K832529
K832529 is an FDA 510(k) premarket notification submitted by Medical Surgical Designs for the device "M.S.D. ASPIRATOR". The FDA issued a decision of Substantially Equivalent on January 4, 1984. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 1984
- Date Received
- July 29, 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