Cleared Traditional

STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD

K911637 · Personal Products Co. · Neurology
Aug 1991
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K911637 is an FDA 510(k) clearance for the STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD, a Rongeur, Powered (Class II — Special Controls, product code HAD), submitted by Personal Products Co. (Milltown, US). The FDA issued a Cleared decision on August 2, 1991, 113 days after receiving the submission on April 11, 1991. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4845.

Submission Details

510(k) Number K911637 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1991
Decision Date August 02, 1991
Days to Decision 113 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary

Device Classification

Product Code HAD — Rongeur, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4845