SURESKIN THIN

K960404 · Euromed A/S · MGP · Mar 1, 1996 · SU

Device Facts

• Record ID: K960404
• Device Name: SURESKIN THIN
• 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® THIN Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of dry to lightly exudating dermal ulcers, post-operative wounds, and superficial wounds and abrasions.

Device Story

SureSkin® THIN Hydrocolloid Wound Dressing; sterile, occlusive dressing for wound management. Composed of hydrocolloid contact layer and polyurethane film backing. Used in clinical or home settings by patients or healthcare providers. Provides moist wound environment to facilitate healing; protects wound from external contaminants. Applied topically to dry to lightly exudating wounds; post-operative sites; superficial wounds; abrasions. Benefits include protection and maintenance of optimal healing conditions.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in conformance with Tripartite and ISO 10993 recommendations; results demonstrate suitability for intended use.

Technological Characteristics

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

Indications for Use

Indicated for management of dry to lightly exudating dermal ulcers, post-operative wounds, and superficial wounds and abrasions in patients requiring wound care.

Predicate Devices

• DuoDERM Extra Thin Flexible Hydrocolloid Dressing

Submission Summary (Full Text)

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510(k) SUMMARY
SureSkin® THIN Hydrocolloid Wound Dressing
K960404

# 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® THIN 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® THIN Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of dry to lightly exudating dermal ulcers, post-operative wounds, and superficial wounds and abrasions. It is composed of a hydrocolloid material which is in contact with the wound, and an occlusive polyurethane.

Euromed SureSkin™ THIN 510(k)
1/25/96
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film backing. The dressing is similar in design, function, materials, and intended use to other hydrocolloid/occlusive dressings currently in commercial distribution, e.g., DuoDERM Extra Thin Flexible Hydrocolloid Dressing.

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™ THIN 510(k)
1/25/96
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