LONG HANDLED SPONGE— 510(k) K761125

Substantially Equivalent

Fred Sammons, Inc.

FDA 510(k) clearance K761125 for LONG HANDLED SPONGE, Substantially Equivalent on 1976-12-02. Applicant: Fred Sammons, Inc..

Clearance details

Applicant: Fred Sammons, Inc.
Product code: Code ILS
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 ↗

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.