DERMAPLEX HYDROGEL WOUND DRESSING— 510(k) K962513

Substantially Equivalent for Some Indications

Maxxim Medical

FDA 510(k) clearance K962513 for DERMAPLEX HYDROGEL WOUND DRESSING, Substantially Equivalent for Some Indications on 1996-09-12. Applicant: Maxxim Medical. Device class: Unclassified.

Clearance details

Applicant
Maxxim Medical
Product code
Code MGQ
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent for Some Indications
Clearance type
Traditional
Location
Fort Worth, TX, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MGQ

product code MGQ
Death
16
Total
16

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 →

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