Cyclotech Cyclosporine Oral Solutions Dispenser

FDA 510(k) K980109 · Sangstat Medical Corp.

Substantially Equivalent

510(k) numberK980109

Submission

Device name
Cyclotech Cyclosporine Oral Solutions Dispenser
Applicant
Sangstat Medical Corp.
Fremont, CA, US
Received
January 12, 1998
Decision date
August 18, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KYX – Dispenser, Liquid Medication
Device class
Class I (low risk)
Regulation
21 CFR 880.6430
Specialty
General Hospital

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Questions and answers

When was Cyclotech Cyclosporine Oral Solutions Dispenser cleared by the FDA?

Cyclotech Cyclosporine Oral Solutions Dispenser (K980109) received a 510(k) decision of Substantially Equivalent on August 18, 1998, 218 days after the submission was received.

What is the product code of K980109?

The FDA product code is KYX – Dispenser, Liquid Medication, a Class I (low risk) device regulated under 21 CFR 880.6430.