Cleared Traditional

LARYNGEAL

K853726 · Hood Laboratories · Ear, Nose, Throat
Mar 1986
Decision
187d
Days
Class 2
Risk

About This 510(k) Submission

K853726 is an FDA 510(k) clearance for the LARYNGEAL, a Prosthesis, Larynx (stents And Keels) (Class II — Special Controls, product code FWN), submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on March 12, 1986, 187 days after receiving the submission on September 6, 1985. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K853726 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 1985
Decision Date March 12, 1986
Days to Decision 187 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code FWN — Prosthesis, Larynx (stents And Keels)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3620

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