510(k) K904612
K904612 is an FDA 510(k) premarket notification submitted by Medical Technical Products for the device "I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)". The FDA issued a decision of Substantially Equivalent on December 26, 1990. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Medical Technical Products has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 26, 1990
- Date Received
- October 11, 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