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510(k) Data Aggregation
K Number
K030239Device Name
MEGATECH SCIENTIFIC FACE MASK
Manufacturer
Date Cleared
2003-07-24
(182 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
MEGATECH SCIENTIFIC PTE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
THE SURGICAL FACE MASK IS INTENDED TO BE WORN BY OPERATING ROOM PERSONNEL DURING SURGICAL PROCEDURES TO PROTECT BOTH THE SURGICAL PATIENT AND THE OPERATING ROOM PERSONNEL FROM TRANSFER OF MICRO-ORGANISMS, BODY FLUIDS AND PARTICULATE MATERIAL.
Device Description
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