510(k) K854052
K854052 is an FDA 510(k) premarket notification submitted by Northern Scientific, Inc. for the device "CSM MEDIUM". The FDA issued a decision of Substantially Equivalent on December 31, 1985. The device falls under product code LYX (Media, Corneal Storage), a Class U device. Northern Scientific, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 1985
- Date Received
- October 3, 1985
- 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