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510(k) Data Aggregation
K Number
K030831Device Name
LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPSManufacturer
Date Cleared
2004-06-15
(459 days)
Product Code
Regulation Number
878.4400Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The instrument is used to cut and coagulate the selected tissue for Laparoscopic procedure.
Device Description
Not Found
AI/ML Overview
This document is a letter from the FDA regarding clearance for "Laparoscopic Instruments and Electrode Tips" and an "Indications for Use" statement. It does not contain information about acceptance criteria or a study proving how the device meets those criteria. Therefore, I cannot extract the requested information from the provided text.
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