Cleared Traditional

K893909 - MODIFIED MATERIAL USED IN INFUSION T
(FDA 510(k) Clearance)

K893909 · Quinton, Inc. · General Hospital

Aug 1989

Decision

87d

Days

Class 2

Risk

K893909 is an FDA 510(k) clearance for the MODIFIED MATERIAL USED IN INFUSION T, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on August 25, 1989, 87 days after receiving the submission on May 30, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K893909 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 1989
Decision Date	August 25, 1989
Days to Decision	87 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—