510(k) K980109

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

K980109 is an FDA 510(k) premarket notification submitted by Sangstat Medical Corp. for the device "CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER". The FDA issued a decision of Substantially Equivalent on August 18, 1998. The device falls under product code KYX (Dispenser, Liquid Medication), a Class I device regulated under 21 CFR 880.6430. Sangstat Medical Corp. has at least 2 other 510(k) clearances on record.