Cleared Traditional

SLICK SET W/SURELOC EXTERNAL CONNECTOR

K810151 · Polamedco, Inc. · Anesthesiology
Feb 1981
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K810151 is an FDA 510(k) clearance for the SLICK SET W/SURELOC EXTERNAL CONNECTOR, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Polamedco, Inc. (Walker, US). The FDA issued a Cleared decision on February 12, 1981, 22 days after receiving the submission on January 21, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K810151 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 1981
Decision Date February 12, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

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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