SURESKIN STANDARD— 510(k) K960394

Substantially Equivalent for Some Indications

Euromed A/S

FDA 510(k) clearance K960394 for SURESKIN STANDARD, Substantially Equivalent for Some Indications on 1996-03-01. Applicant: Euromed A/S.

Clearance details

Applicant
Euromed A/S
Product code
Code MGP
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent for Some Indications
Clearance type
Traditional
Location
North Attleboro, MA, 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.