Search Results
Found 2 results
510(k) Data Aggregation
K Number
K974348Device Name
ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING
Manufacturer
LABORATOIRES URGO S.A.
Date Cleared
1998-02-13
(86 days)
Product Code
FRO, MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LABORATOIRES URGO S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Algoplaque Film Extra Thin Hydrocolloid Dressing is a topical wound dressing that is intended for the local management of superficial, dry to lightly-exudating wounds, including pressure sores, dermal ulcers, post-operative wounds or suture sites, and abrasions and lacerations.
Algoplaque Film Extra Thin Hydrocolloid Dressings are also suitable for use as protective skin coverings.
Algoplaque Film Extra Thin Hydrocolloid Dressings are not intended for use on third degree burns.
Device Description
ALGOPLAQUE FILM is a flexible, semiocclusive, topical wound dressing that consists of a polyurethane backing sheet and a hydrocolloid layer. The hydrocolloid layer interacts with wound exudate - liquifying into a soft gel. This gel enables the dressing to be removed with minimal trauma to the underlying tissues.
Ask a Question
K Number
K970518Device Name
ALGOPLAQUE HYDROCOLLOID DRESSING
Manufacturer
LABORATOIRES URGO S.A.
Date Cleared
1997-03-21
(38 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LABORATOIRES URGO S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1