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510(k) Data Aggregation
K Number
K971337Device Name
EPITECH ISLAND DRESSINGS
Manufacturer
RYNEL LTD, INC.
Date Cleared
1997-07-09
(90 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
RYNEL LTD, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rynel Epitech™ Island Dressing is intended for use in the local management of sureral incisions. Iacerations. trauma inflicted wounds, abrasions, superficial burns, secondate dressings for packed wounds and donor sites. The dressing is also appropriate for prossure diabcuc and venous stasis ulcers. It is intended to be used to protect the skin from octentral irritation, maceration and to manage exudate.
Device Description
The Rynel Epitech™ Island dressing pad will be manufactured from hydrophilic polyurethane foam and the border material will be either a polyurethane film or a nonwoven polyester fabric coated with a nonsensitizing acrylic pressure sensitive adhesive.
The dressing will be offered as sterile stand alone dressings and will be individually packaged. Pouch material and construction will be consistent with current packaging in use by industry to safety package sterile wound dressings.
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