Cleared Traditional

PRIMA GUEDEL AIRWAYS

K952013 · Prima, Inc. · Anesthesiology
May 1995
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K952013 is an FDA 510(k) clearance for the PRIMA GUEDEL AIRWAYS, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Prima, Inc. (Cleveland, US). The FDA issued a Cleared decision on May 22, 1995, 24 days after receiving the submission on April 28, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K952013 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1995
Decision Date May 22, 1995
Days to Decision 24 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

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