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510(k) Data Aggregation
K Number
K973260Device Name
HYDRASORB STERILE DRESSING
Manufacturer
AVITAR, INC.
Date Cleared
1997-10-21
(53 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
AVITAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Avitar Hydrasorb Sterile Dressings are external wound dressings designed to provide a moiest healing environment, manage exudate, and protect the wound from contamination. Hydrasorb Sterile Dressings are indicated as external wound dressings for use in the local management of external wounds such as post surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, superficial burns, other external wounds inflicted by trauma, and as a secondary dressing or cover dressing for packed wounds. Hydrasorb Sterile Dressing -Fenestrated also absorbs fluid quickly and efficiently and maintains a moist wound healing environment. is an ideal dressing in the local management of exudate that may occur at surgically induced body drainage sites such as a tracheostomy, G-tube, J-tube, Penrose drain, chest tube, nephrotomy tube, or sump In generallit can be used anywhere there is a need to manage drain. the surrounding skin due to potential skin irritation or maceration.
Device Description
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