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510(k) Data Aggregation
K Number
K961773Device Name
PROTEC STERILE GAUZE SPONGE
Manufacturer
DERIVADAS DEGASA S.A. DE C.V.
Date Cleared
1996-07-29
(82 days)
Product Code
EFQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DERIVADAS DEGASA S.A. DE C.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DeGasa Sterile USP Gauze Sponges are used in a hospital setting where sterile gauze is required. The instructions for use by physicians using gauze sponges are exactly the same as the instructions for use found on present labeling for similar products currently on the market.
Device Description
DeGasa USP Gauze are sterile gauze sponges that are made with 100 % cotton, and are in the form of plain woven cloth conforming to the specifications of USP type VII.
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K Number
K960093Device Name
PROTEC ROLL GAUZE
Manufacturer
DERIVADAS DEGASA S.A. DE C.V.
Date Cleared
1996-03-25
(74 days)
Product Code
EFQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DERIVADAS DEGASA S.A. DE C.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955320Device Name
PROTEC COTTON PADDING BANDAGE
Manufacturer
DERIVADAS DEGASA S.A. DE C.V.
Date Cleared
1996-01-26
(67 days)
Product Code
LGF
Regulation Number
888.5940Why did this record match?
Applicant Name (Manufacturer) :
DERIVADAS DEGASA S.A. DE C.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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