510(k) K182986
K182986 is an FDA 510(k) premarket notification submitted by Massachusetts Eye and Ear Infirmary D/B/A Boston for the device "Boston Keratoprosthesis, Type I Lucia". The FDA issued a decision of Substantially Equivalent on January 30, 2019. The device falls under product code HQM (Keratoprosthesis, Permanent Implant), a Class II device regulated under 21 CFR 886.3400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2019
- Date Received
- October 29, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Keratoprosthesis, Permanent Implant
- Device Class
- Class II
- Regulation Number
- 886.3400
- Review Panel
- OP
- Submission Type