Search Results
Found 4 results
510(k) Data Aggregation
K Number
K963039Device Name
SURESKIN STANDARD, BORDER, AND THIN
Manufacturer
EUROMED A/S
Date Cleared
1996-09-23
(49 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EUROMED A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
indicated for the management of dry and exudating pressure sores and leg ulcers.
Device Description
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.
Ask a Question
K Number
K960393Device Name
SURESKIN BORDER
Manufacturer
EUROMED A/S
Date Cleared
1996-03-01
(32 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EUROMED A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
indicated for the management of lightly to heavily exudating pressure sores and leg ulcers.
Device Description
The SureSkin® BORDER Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of lightly to heavily exudating pressure 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.
Ask a Question
K Number
K960394Device Name
SURESKIN STANDARD
Manufacturer
EUROMED A/S
Date Cleared
1996-03-01
(32 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EUROMED A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
indicated for the management of light to heavy exudating pressure sores and leg ulcers.
Device Description
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. It is composed of a hydrocolloid material which is in contact with the wound, and an occlusive polyurethane backing.
Ask a Question
K Number
K960404Device Name
SURESKIN THIN
Manufacturer
EUROMED A/S
Date Cleared
1996-03-01
(32 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EUROMED A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
indicated for the management of dry to lightly exudating dermal ulcers, post-operative wounds, and superficial wounds and abrasions.
Device Description
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 film backing.
Ask a Question
Page 1 of 1