LONG HANDLED BATH BRUSH— 510(k) K761127

Name: FDA 510(k) clearance K761127
Creator: U.S. Food and Drug Administration
Published: 1976-12-02

Substantially Equivalent

Fred Sammons, Inc.

FDA 510(k) clearance K761127 for LONG HANDLED BATH BRUSH, Substantially Equivalent on 1976-12-02. Applicant: Fred Sammons, Inc.. Device class: 1.

Clearance details

Applicant: Fred Sammons, Inc.
Product code: Code ILS
Device class: Class 1
Regulation: 21 CFR 890.5050
Advisory panel: Physical Medicine
Date received: 1976-11-19
Decision date: 1976-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ILS

product code ILS

Death: 4
Injury: 200
Total: 204

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.