Cleared Traditional

K772167 - EMIT LIDOCAINE CONTROL (FDA 510(k) Clearance)

Nov 1977
Decision
6d
Days
Class 2
Risk

K772167 is an FDA 510(k) clearance for the EMIT LIDOCAINE CONTROL. This device is classified as a Calibrators, Drug Specific (Class II - Special Controls, product code DLJ).

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1977, 6 days after receiving the submission on November 16, 1977.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K772167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1977
Decision Date November 22, 1977
Days to Decision 6 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary

Device Classification

Product Code DLJ — Calibrators, Drug Specific
Device Class Class II - Special Controls
CFR Regulation 21 CFR 862.3200