Cleared Traditional

SURGICAL TRAY (STERILE)

K925022 · Customed, Inc. · Ear, Nose, Throat
Apr 1993
Decision
214d
Days
Class 1
Risk

About This 510(k) Submission

K925022 is an FDA 510(k) clearance for the SURGICAL TRAY (STERILE), a Applicator, Ent Drug (Class I — General Controls, product code LRD), submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on April 26, 1993, 214 days after receiving the submission on September 24, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5220.

Submission Details

510(k) Number K925022 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1992
Decision Date April 26, 1993
Days to Decision 214 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code LRD — Applicator, Ent Drug
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.5220