510(k) K863129
K863129 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M CORNEAL SYSTEM (CORNEAL PRESERVATION MEDIUM)". The FDA issued a decision of Substantially Equivalent on September 17, 1986. The device falls under product code LYX (Media, Corneal Storage), a Class U device. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 1986
- Date Received
- August 15, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Corneal Storage
- Device Class
- Class U
- Regulation Number
- Review Panel
- OP
- Submission Type