Cleared Traditional

K860881 - CATHETER MOUNTS & ELBOWS (VARIOUS TYPES)
(FDA 510(k) Clearance)

Mar 1986
Decision
22d
Days
Class 1
Risk

K860881 is an FDA 510(k) clearance for the CATHETER MOUNTS & ELBOWS (VARIOUS TYPES). This device is classified as a Connector, Airway (extension) (Class I - General Controls, product code BZA).

Submitted by Dhd Medical Products Div. Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on March 19, 1986, 22 days after receiving the submission on February 25, 1986.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5810.

Submission Details

510(k) Number K860881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1986
Decision Date March 19, 1986
Days to Decision 22 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

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

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