Cleared Traditional

K980109 - CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER
(FDA 510(k) Clearance)

K980109 · Sangstat Medical Corp. · General Hospital

Aug 1998

Decision

218d

Days

Class 1

Risk

K980109 is an FDA 510(k) clearance for the CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER, a Dispenser, Liquid Medication (Class I — General Controls, product code KYX), submitted by Sangstat Medical Corp. (Fremont, US). The FDA issued a Cleared decision on August 18, 1998, 218 days after receiving the submission on January 12, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6430.

Submission Details

510(k) Number	K980109 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 12, 1998
Decision Date	August 18, 1998
Days to Decision	218 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF