Cleared Traditional

SURELOC CIRCUIT CONNECTOR

K954383 · Polamedco, Inc. · Anesthesiology
Dec 1995
Decision
94d
Days
Class 1
Risk

About This 510(k) Submission

K954383 is an FDA 510(k) clearance for the SURELOC CIRCUIT CONNECTOR, a Connector, Airway (extension) (Class I — General Controls, product code BZA), submitted by Polamedco, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on December 22, 1995, 94 days after receiving the submission on September 19, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5810.

Submission Details

510(k) Number K954383 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1995
Decision Date December 22, 1995
Days to Decision 94 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZA — Connector, Airway (extension)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5810

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