Cleared Traditional

TIGER BAND

K844324 · World Wide Outdoor Marketing · Dental
Dec 1984
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K844324 is an FDA 510(k) clearance for the TIGER BAND, a Instruments, Dental Hand (Class I — General Controls, product code DZN), submitted by World Wide Outdoor Marketing (Minden, US). The FDA issued a Cleared decision on December 3, 1984, 26 days after receiving the submission on November 7, 1984. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K844324 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1984
Decision Date December 03, 1984
Days to Decision 26 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code DZN — Instruments, Dental Hand
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565