Cleared Traditional

PREMIER MIRROR WARMER

K945395 · Premier Dental Products Co. · Ear, Nose, Throat
Jan 1995
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K945395 is an FDA 510(k) clearance for the PREMIER MIRROR WARMER, a Unit, Examining/treatment, Ent (Class I — General Controls, product code ETF), submitted by Premier Dental Products Co. (Philadelphia, US). The FDA issued a Cleared decision on January 18, 1995, 76 days after receiving the submission on November 3, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5300.

Submission Details

510(k) Number K945395 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 1994
Decision Date January 18, 1995
Days to Decision 76 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

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