HYPO CLENZ WOUND WASH MODEL 100 PPM— 510(k) K100948

Substantially Equivalent

Nevoa Life Sciences, LLC

FDA 510(k) clearance K100948 for HYPO CLENZ WOUND WASH MODEL 100 PPM, Substantially Equivalent on 2011-02-02. Applicant: Nevoa Life Sciences, LLC.

Clearance details

Applicant: Nevoa Life Sciences, LLC
Product code: Code FRO
Advisory panel: Unknown
Date received: 2010-04-06
Decision date: 2011-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmichael, CA, US

Download summary PDF View on FDA.gov ↗

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.