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FDA 510(k)

SURESKIN BORDER

K-Number: K960393 · 1996-03-01

ApplicantEuromed A/S
Decision Date1996-03-01
Product CodeMGP
DecisionSubstantially Equivalent for Some Indications

Device Summary

SURESKIN BORDER is the device name listed in this FDA 510(k) record. The listed applicant is Euromed A/S. It received FDA 510(k) clearance on 1996-03-01 under 510(k) number K960393. The device is classified under product code MGP. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SURESKIN BORDER?

SURESKIN BORDER is a medical device that received FDA 510(k) clearance on 1996-03-01. The listed applicant is Euromed A/S. The 510(k) number is K960393.

When did SURESKIN BORDER receive FDA 510(k) clearance?

SURESKIN BORDER received FDA 510(k) clearance on 1996-03-01, under 510(k) number K960393.

Who is the listed applicant for SURESKIN BORDER?

The FDA 510(k) record lists Euromed A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURESKIN BORDER?

The FDA product code for SURESKIN BORDER is MGP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Euromed A/S as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K963039SURESKIN STANDARD, BORDER, AND THINK960394SURESKIN STANDARDK960404SURESKIN THIN

Related Devices (Code: MGP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K012995COLLATEK SHEETBiocore Medical Technologies, Inc.K012997COLLATEK FOAMBiocore Medical Technologies, Inc.K001508LASERSKIN DRESSINGFidia Advanced Biopolymers SrlK990079FASTSEAL CHEST WOUND DRESSINGGreenfield Medical Technologies, Inc.K991214SIMPLICARE TRANSPARENT WOUND DRESSINGHollister, Inc.K992302DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORSDermaphylyx, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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