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510(k) Data Aggregation
K Number
K992604Device Name
HENRY SCHEIN SURGICAL MASK
Manufacturer
Date Cleared
2000-01-28
(178 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
MITSUI TEXTILE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The indication for use of the Henry Schein surgical mask is as follows. These surgical masks are surgical apparel, intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Device Description
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