STERILE ABSORBENT GAUZE BURN & SOUND— 510(k) K840745

Substantially Equivalent

Chesebrough-Pond'S U.S.A. Co.

FDA 510(k) clearance K840745 for STERILE ABSORBENT GAUZE BURN & SOUND, Substantially Equivalent on 1984-04-23. Applicant: Chesebrough-Pond'S U.S.A. Co..

Clearance details

Applicant: Chesebrough-Pond'S U.S.A. Co.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1984-02-22
Decision date: 1984-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.