510(k) K081681
K081681 is an FDA 510(k) premarket notification submitted by Advanced Medical Optics, Inc. for the device "VITRECTOMY CUTTER AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on October 8, 2008. The device falls under product code MLZ (Vitrectomy, Instrument Cutter), a Class II device regulated under 21 CFR 886.4150. Advanced Medical Optics, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2008
- Date Received
- June 17, 2008
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vitrectomy, Instrument Cutter
- Device Class
- Class II
- Regulation Number
- 886.4150
- Review Panel
- OP
- Submission Type