DeviceClearance

SILVER ALGINATE 11 WOUND DRESSING— 510(k) K090453

Substantially Equivalent

Advanced Medical Solutions Limited

FDA 510(k) clearance K090453 for SILVER ALGINATE 11 WOUND DRESSING, Substantially Equivalent on 2009-02-26. Applicant: Advanced Medical Solutions Limited. Device class: Unclassified.

Clearance details

Applicant
Advanced Medical Solutions Limited
Product code
Code FRO
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Winsford, Cheshire, GB
Download summary PDFView on FDA.gov ↗

Recent devices under product code FRO

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More clearances from Advanced Medical Solutions Limited

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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, 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 →

Recalls naming K090453

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090453.

Data sourced from openFDA. This site is unofficial and independent of the FDA.