SURESKIN THIN— 510(k) K960404

Name: FDA 510(k) clearance K960404
Creator: U.S. Food and Drug Administration
Published: 1996-03-01

Substantially Equivalent for Some Indications

Euromed A/S

FDA 510(k) clearance K960404 for SURESKIN THIN, Substantially Equivalent for Some Indications on 1996-03-01. Applicant: Euromed A/S. Device class: Unclassified.

Clearance details

Applicant: Euromed A/S
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1996-01-29
Decision date: 1996-03-01
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MGP

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K012995 — COLLATEK SHEET2001-10-25
K012997 — COLLATEK FOAM2001-10-25
K001508 — LASERSKIN DRESSING2001-07-25
K990079 — FASTSEAL CHEST WOUND DRESSING1999-12-23
K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING1999-10-14

More clearances from Euromed A/S

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K963039 — SURESKIN STANDARD, BORDER, AND THIN1996-09-23
K960393 — SURESKIN BORDER1996-03-01
K960394 — SURESKIN STANDARD1996-03-01

Adverse events under product code MGP

product code MGP

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.