Cleared Traditional

K932711 - PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS
(FDA 510(k) Clearance)

Jul 1993
Decision
49d
Days
Class 2
Risk

K932711 is an FDA 510(k) clearance for the PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS. This device is classified as a Tube, Tracheal (w/wo Connector) (Class II - Special Controls, product code BTR).

Submitted by Precision Med Products, Ltd. (Marrtinsville, US). The FDA issued a Cleared decision on July 23, 1993, 49 days after receiving the submission on June 4, 1993.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K932711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1993
Decision Date July 23, 1993
Days to Decision 49 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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