DeviceClearance

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

Substantially Equivalent

Premier Brands of America, Inc.

FDA 510(k) clearance K090848 for PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM, Substantially Equivalent on 2009-06-17. Applicant: Premier Brands of America, Inc.. Device class: 2.

Clearance details

Applicant
Premier Brands of America, Inc.
Product code
Code FQH
Device class
Class 2
Regulation
21 CFR 880.5475
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mount Vernon, NY, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code FQH

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Adverse events under product code FQH

product code FQH
Injury
170
Malfunction
2,513
Other
1
Total
2,684

Source: openFDA MAUDE database, through . 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.