The following data is part of a premarket notification filed by Northern Scientific, Inc. with the FDA for Dexsol.
Device ID | K883854 |
510k Number | K883854 |
Device Name: | DEXSOL |
Classification | Media, Corneal Storage |
Applicant | NORTHERN SCIENTIFIC, INC. 688 MAIN ST. Buffalo, NY 14202 |
Contact | Carol Houenstein |
Correspondent | Carol Houenstein NORTHERN SCIENTIFIC, INC. 688 MAIN ST. Buffalo, NY 14202 |
Product Code | LYX |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-13 |
Decision Date | 1988-11-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DEXSOL 74376597 1818714 Dead/Cancelled |
Chiron Corporation 1993-04-07 |