DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING— 510(k) K990438

Substantially Equivalent

Dermaphylyx, Inc.

FDA 510(k) clearance K990438 for DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING, Substantially Equivalent on 1999-03-25. Applicant: Dermaphylyx, Inc..

Clearance details

Applicant
Dermaphylyx, Inc.
Product code
Code MGP
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Arvada, CO, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MGP

product code MGP
Other
1
Total
1

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.