Cleared Traditional

K781759 - RESCAL
(FDA 510(k) Clearance)

K781759 · Diemolding Corp. · Anesthesiology
Nov 1978
Decision
42d
Days
Class 1
Risk

K781759 is an FDA 510(k) clearance for the RESCAL. This device is classified as a Connector, Airway (extension) (Class I — General Controls, product code BZA).

Submitted by Diemolding Corp. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1978, 42 days after receiving the submission on October 16, 1978.

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

Submission Details

510(k) Number K781759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1978
Decision Date November 27, 1978
Days to Decision 42 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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