Cleared Traditional

K860877 - FLEXTUBE, CONNECTING TUBING
(FDA 510(k) Clearance)

Mar 1986
Decision
23d
Days
Class 1
Risk

K860877 is an FDA 510(k) clearance for the FLEXTUBE, CONNECTING TUBING. This device is classified as a Tubing, Pressure And Accessories (Class I - General Controls, product code BYX).

Submitted by Dhd Medical Products Div. Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on March 20, 1986, 23 days after receiving the submission on February 25, 1986.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5860.

Submission Details

510(k) Number K860877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1986
Decision Date March 20, 1986
Days to Decision 23 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code BYX — Tubing, Pressure And Accessories
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.5860

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