510(k) K895013
K895013 is an FDA 510(k) premarket notification submitted by Ocular Instruments, Inc. for the device "COBO TEMPORARY KERATOPROSTHESIS". The FDA issued a decision of Substantially Equivalent on October 31, 1989. The device falls under product code MLP (Keratoprosthesis, Temporary Implant, Surgical Use), a Class II device regulated under 21 CFR 886.3400. Ocular Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1989
- Date Received
- August 8, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Keratoprosthesis, Temporary Implant, Surgical Use
- Device Class
- Class II
- Regulation Number
- 886.3400
- Review Panel
- OP
- Submission Type