510(k) K980109

CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER by Sangstat Medical Corp. — Product Code KYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1998
Date Received
January 12, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dispenser, Liquid Medication
Device Class
Class I
Regulation Number
880.6430
Review Panel
HO
Submission Type