SURESKIN STANDARD

K960394 · Euromed A/S · MGP · Mar 1, 1996 · SU

Device Facts

• Record ID: K960394
• Device Name: SURESKIN STANDARD
• Applicant: Euromed A/S
• Product Code: MGP · SU
• Decision Date: Mar 1, 1996
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

The SureSkin® STANDARD Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of light to heavy exudating pressure sores and leg ulcers.

Device Story

Hydrocolloid wound dressing; consists of hydrocolloid contact layer and occlusive polyurethane backing; used for management of exudating pressure sores and leg ulcers; applied by clinicians or patients; provides moist wound environment; facilitates healing; protects wound site.

Clinical Evidence

Bench testing only; biocompatibility testing performed in conformance with Tripartite and ISO 10993 recommendations.

Technological Characteristics

Hydrocolloid material contact layer; occlusive polyurethane backing; biocompatibility per ISO 10993.

Indications for Use

Indicated for patients with light to heavy exudating pressure sores and leg ulcers.

Predicate Devices

• DuoDerm Dressing (Convatec)

Submission Summary (Full Text)

{0}

510(k) SUMMARY
K 960394
SureSkin® STANDARD Hydrocolloid Wound Dressing

1. DATE PREPARED
January 25, 1996

2. SUBMITTER
Euromed A/S
Borgergade 6
DK-1300 Copenhagen
Denmark

3. CONTACT
Mr. Carsten Fredsbo
General Manager
Phone: [phone]

4. DEVICE NAME
SureSkin® STANDARD Hydrocolloid Wound Dressing

5. DEVICE CLASSIFICATION
Wound Dressings have not been finally classified by FDA.
[Proposed Class I (21 CFR 878.4022)]
Product Code: 79 MGP

6. DEVICE DESCRIPTION AND COMPARISON TO PREDICATE PRODUCTS
The SureSkin® STANDARD Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of light to heavy exudating pressure

Euromed SureSkin™ STANDARD 510(k)
1/25/96
Page D-1

{1}

sores and leg ulcers. It is composed of a hydrocolloid material which is in contact with the wound, and an occlusive polyurethane backing. The dressing is similar in design, function, materials, and intended use to other hydrocolloid/occlusive dressings currently in commercial distribution, e.g., DuoDerm Dressing marketed by Convatec.

Determination of substantial equivalence for this product was based on descriptive information about the design, materials, and intended use of the device. Biocompatibility testing was performed on the device material in conformance with Tripartite and ISO 10993 recommendations. Results of all biocompatibility tests demonstrated that the device is suitable for its intended use.

Euromed SureSkin™ STANDARD 510(k)
1/25/96
Page D-2
13