510(k) K090848— PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM

Substantially Equivalent

Premier Brands of America, Inc.

Clearance details

Applicant: Premier Brands of America, Inc.
Product code: Code FQH
Advisory panel: General Hospital
Date received: 2009-03-30
Decision date: 2009-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mount Vernon, NY, US

Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

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.