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510(k) Data Aggregation
K Number
K963568Device Name
MASK SURGICAL
Manufacturer
Date Cleared
1997-02-25
(173 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
THE INNOVATIVE APPROACH, CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The INTENDED MEDICAL USE is to protect the healthcare personnel and patient from transfer of microorganisms, body fluids and particulate material.
Device Description
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