Cleared Traditional

K781808 - SLICK SET, CUFFED
(FDA 510(k) Clearance)

Nov 1978
Decision
37d
Days
Class 2
Risk

K781808 is an FDA 510(k) clearance for the SLICK SET, CUFFED. This device is classified as a Tube, Tracheal (w/wo Connector) (Class II - Special Controls, product code BTR).

Submitted by Polamedco, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 29, 1978, 37 days after receiving the submission on October 23, 1978.

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

Submission Details

510(k) Number K781808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1978
Decision Date November 29, 1978
Days to Decision 37 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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