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510(k) Data Aggregation
K Number
K962972Device Name
SURGICADE GAUZE SPONGE
Manufacturer
Date Cleared
1996-10-11
(72 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ACCUNEX CANADA,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Control bleeding, absorb body fluids, and protect wounds from contamination.
Device Description
Surgicade™ Non-Sterile Gauze Sponges are composed of USP Type VII gauze, ourgical on the each Spire Care Spirity and Compose of Carrype of Suble available in thicknesses of 8 ply (2" x 2", 4" x 4", 4" x 8"), 12 ply (2" x 2", 3" x 3", 4" x 4", 4"
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