DeviceClearance

E-Z DERM BIOSYNTHETIC WOUND DRESSING— 510(k) K935189

Substantially Equivalent for Some Indications

Brennen Medical, Inc.

FDA 510(k) clearance K935189 for E-Z DERM BIOSYNTHETIC WOUND DRESSING, Substantially Equivalent for Some Indications on 1994-07-11. Applicant: Brennen Medical, Inc.. Device class: Unclassified.

Clearance details

Applicant
Brennen Medical, Inc.
Product code
Code KGN
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent for Some Indications
Clearance type
Traditional
Location
St. Paul, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KGN

product code KGN
Other
2
Total
2

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 K935189

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 K935189.

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