Cleared Traditional

#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES

K910781 · Midmark Corp. · Ear, Nose, Throat
May 1991
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K910781 is an FDA 510(k) clearance for the #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES, a Unit, Examining/treatment, Ent (Class I — General Controls, product code ETF), submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on May 15, 1991, 79 days after receiving the submission on February 25, 1991. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5300.

Submission Details

510(k) Number K910781 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1991
Decision Date May 15, 1991
Days to Decision 79 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code ETF — Unit, Examining/treatment, Ent
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.5300