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510(k) Data Aggregation
K Number
K050656Device Name
AMSINO SUTURE REMOVAL KITManufacturer
Date Cleared
2005-05-02
(49 days)
Product Code
Regulation Number
878.4800Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
AMSINO SUTURE REMOVAL KIT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The AMSINO® Suture Removal Kit is intended for use in suture removal procedures.
Device Description
Not Found
AI/ML Overview
This is a letter acknowledging receipt of a 510(k) premarket notification for the AMSINO® Suture Removal Kit. It does not contain information about acceptance criteria or a study proving device performance. Therefore, I cannot provide the requested details.
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