510(k) K883854
K883854 is an FDA 510(k) premarket notification submitted by Northern Scientific, Inc. for the device "DEXSOL". The FDA issued a decision of Substantially Equivalent on November 16, 1988. 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
- November 16, 1988
- Date Received
- September 13, 1988
- 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