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510(k) Data Aggregation
K Number
K003028Manufacturer
Date Cleared
2000-11-24
(57 days)
Product Code
Regulation Number
878.5035Type
TraditionalReference & Predicate Devices
N/A
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Device Name :
CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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