Cleared Traditional

TRACHEOSTOMY CARE KIT

K952416 · Medi-Flex Hospital Products, Inc. · Anesthesiology
Aug 1995
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K952416 is an FDA 510(k) clearance for the TRACHEOSTOMY CARE KIT, a Tube, Tracheostomy (w/wo Connector) (Class II — Special Controls, product code BTO), submitted by Medi-Flex Hospital Products, Inc. (El Paso, US). The FDA issued a Cleared decision on August 9, 1995, 78 days after receiving the submission on May 23, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K952416 FDA.gov
FDA Decision Cleared SESK
Date Received May 23, 1995
Decision Date August 09, 1995
Days to Decision 78 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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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