Cleared Traditional

MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT

K872710 · Directed Energy, Inc. · Ear, Nose, Throat
Sep 1987
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K872710 is an FDA 510(k) clearance for the MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT, a Laser, Ent Microsurgical Carbon-dioxide (Class II — Special Controls, product code EWG), submitted by Directed Energy, Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 24, 1987, 79 days after receiving the submission on July 7, 1987. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4500.

Submission Details

510(k) Number K872710 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1987
Decision Date September 24, 1987
Days to Decision 79 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
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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