Cleared Traditional

REACH ANTIBACTERIAL TOOTHBRUSH

K971589 · Personal Products Co. · Dental
Jul 1997
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K971589 is an FDA 510(k) clearance for the REACH ANTIBACTERIAL TOOTHBRUSH, a Toothbrush, Manual (Class I — General Controls, product code EFW), submitted by Personal Products Co. (Skillman, US). The FDA issued a Cleared decision on July 24, 1997, 84 days after receiving the submission on May 1, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.6855.

Submission Details

510(k) Number K971589 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1997
Decision Date July 24, 1997
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFW — Toothbrush, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6855

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