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510(k) Data Aggregation
K Number
K103713Device Name
ELTA WOUND CLEANSER
Manufacturer
SWISS AMERICAN PRODUCTS, INC.
Date Cleared
2011-06-16
(177 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SWISS AMERICAN PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Elta Wound Cleanser is intended for the removal of foreign material, such as debris and dirt, from dermal wounds.
Device Description
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K Number
K073610Device Name
ELTA ADVANCED WOUND WASH
Manufacturer
SWISS AMERICAN PRODUCTS, INC.
Date Cleared
2008-04-23
(124 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SWISS AMERICAN PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Advanced Wound Wash is intended for the removal of foreign material, such as debris and dirt, from dermal wounds.
Device Description
Not Found
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K Number
K071703Device Name
ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
Manufacturer
SWISS AMERICAN PRODUCTS, INC.
Date Cleared
2007-08-22
(62 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SWISS AMERICAN PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Elta Silver Antimicrobial Wound Gel is indicated for the management of minor burns, superficial cuts, lacerations, abrasion and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
Device Description
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