Cleared Traditional

CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE

K853419 · Hood Laboratories · Anesthesiology
Dec 1985
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K853419 is an FDA 510(k) clearance for the CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE, a Tube, Tracheostomy (w/wo Connector) (Class II — Special Controls, product code BTO), submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on December 6, 1985, 114 days after receiving the submission on August 14, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K853419 FDA.gov
FDA Decision Cleared SESD
Date Received August 14, 1985
Decision Date December 06, 1985
Days to Decision 114 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BTO — Tube, Tracheostomy (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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