WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553— 510(k) K083355

Substantially Equivalent

Blairex Laboratories, Inc.

FDA 510(k) clearance K083355 for WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553, Substantially Equivalent on 2008-12-29. Applicant: Blairex Laboratories, Inc..

Clearance details

Applicant: Blairex Laboratories, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2008-11-13
Decision date: 2008-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, IN, 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.