SURESKIN STANDARD, BORDER, AND THIN

K963039 · Euromed A/S · FRO · Sep 23, 1996 · SU

Device Facts

• Record ID: K963039
• Device Name: SURESKIN STANDARD, BORDER, AND THIN
• Applicant: Euromed A/S
• Product Code: FRO · SU
• Decision Date: Sep 23, 1996
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The SureSkin™ Hydrocolloid Wound Dressings manufactured by Euromed A/S are indicated for the management of dry and exudating pressure sores and leg ulcers.

Device Story

Hydrocolloid wound dressings; used for management of dry and exudating pressure sores and leg ulcers. Applied topically to wound site by clinician or patient. Provides moist wound environment to facilitate healing. No changes to device design, materials, or manufacturing since original clearance (K960393, K960394, K960404).

Clinical Evidence

No clinical data included; submission limited to labeling revision for previously cleared devices.

Technological Characteristics

Hydrocolloid wound dressing. No changes to materials or construction from previously cleared versions.

Indications for Use

Indicated for management of dry and exudating pressure sores and leg ulcers. Contraindicated for use on 3rd degree burns.

Predicate Devices

• SureSkin™ BORDER Dressing (K960393)
• SureSkin™ STANDARD Dressing (K960394)
• SureSkin™ THIN Dressing (K960404)

Submission Summary (Full Text)

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SEP 23 1996
5963039

# 510(k) SUMMARY
## SureSkin™ Hydrocolloid Wound Dressings
### Labeling Revision

1. DATE PREPARED
August 2, 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
SureSkin™ BORDER Hydrocolloid Wound Dressing
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

Euromed A/S--510(k)
SureSkin™ Dressings--Label Revisions
8/2/96
Page C-1

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# 6. DEVICE DESCRIPTION AND COMPARISON TO PREDICATE PRODUCTS

The SureSkin™ Hydrocolloid Wound Dressings manufactured by Euromed A/S are indicated for the management of dry and exudating pressure sores and leg ulcers. The devices were originally cleared for marketing under K960393--SureSkin™ BORDER Dressing, K960394--SureSkin™ STANDARD Dressing, and K960404--SureSkin™ THIN Dressing. The only purpose of the current 510(k) premarket notification for these products is to update the device labeling to be consistent with equivalent products. The three dressings will be contraindicated for use on 3rd degree burns. No other changes have been made to the devices since the original marketing clearance was obtained and therefore, no other specific performance or biocompatibility testing was included in this submission.

Euromed A/S--510(k)
SureSkin™ Dressings--Label Revisions
8/2/96
Page C-2