Cleared Traditional

KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE

K961977 · Kendall Healthcare Products Co. Div.Of Tyco Health · Anesthesiology

Jul 1996

Decision

72d

Days

Class 2

Risk

About This 510(k) Submission

K961977 is an FDA 510(k) clearance for the KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE, a Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (Class II — Special Controls, product code CBI), submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on July 31, 1996, 72 days after receiving the submission on May 20, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5740.

Submission Details

510(k) Number	K961977 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 1996
Decision Date	July 31, 1996
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	CBI — Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5740