Cleared Traditional

LASER GAS MIXTURES

K820535 · Union Carbide Corp. · Toxicology
Mar 1982
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K820535 is an FDA 510(k) clearance for the LASER GAS MIXTURES, a Laser, Ent Microsurgical Carbon-dioxide (Class II — Special Controls, product code EWG), submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on March 31, 1982, 29 days after receiving the submission on March 2, 1982. This device falls under the Toxicology review panel. Regulated under 21 CFR 874.4500.

Submission Details

510(k) Number K820535 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 1982
Decision Date March 31, 1982
Days to Decision 29 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code EWG — Laser, Ent Microsurgical Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.4500

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