Cleared Traditional

VITAFLOW SUCTION/ASPIRATION TUBING SET

K960616 · Vital Concepts, Inc. · General Hospital

May 1996

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K960616 is an FDA 510(k) clearance for the VITAFLOW SUCTION/ASPIRATION TUBING SET, a Tube, Aspirating, Flexible, Connecting (Class II — Special Controls, product code BYY), submitted by Vital Concepts, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on May 6, 1996, 83 days after receiving the submission on February 13, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number	K960616 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 1996
Decision Date	May 06, 1996
Days to Decision	83 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement