Cleared Traditional

FLEXTITIP STYLETTE

K950380 · Polamedco, Inc. · Anesthesiology
Feb 1995
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K950380 is an FDA 510(k) clearance for the FLEXTITIP STYLETTE, a Stylet, Tracheal Tube (Class I — General Controls, product code BSR), submitted by Polamedco, Inc. (Inglewood, US). The FDA issued a Cleared decision on February 10, 1995, 10 days after receiving the submission on January 31, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5790.

Submission Details

510(k) Number K950380 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 1995
Decision Date February 10, 1995
Days to Decision 10 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BSR — Stylet, Tracheal Tube
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5790

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