Cleared Traditional

K896586 - RATE INCREASE FOR IPPB/IPV
(FDA 510(k) Clearance)

K896586 · Percussionaire Corp. · Dental
Jan 1990
Decision
48d
Days
Class 1
Risk

K896586 is an FDA 510(k) clearance for the RATE INCREASE FOR IPPB/IPV, a Tube, Orthodontic (Class I — General Controls, product code DZD), submitted by Percussionaire Corp. (Sandpoint, US). The FDA issued a Cleared decision on January 9, 1990, 48 days after receiving the submission on November 22, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K896586 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 1989
Decision Date January 09, 1990
Days to Decision 48 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code DZD — Tube, Orthodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5410