510(k) K915062
K915062 is an FDA 510(k) premarket notification submitted by Mackeen Consultants, Ltd. for the device "DOHLMAN DOANE KERATOPROTHESIS". The FDA issued a decision of Substantially Equivalent on January 21, 1992. The device falls under product code HQM (Keratoprosthesis, Permanent Implant), a Class II device regulated under 21 CFR 886.3400. Mackeen Consultants, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1992
- Date Received
- November 8, 1991
- Clearance Type
- Traditional
- 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