Search Results
Found 1 results
510(k) Data Aggregation
K Number
K984389Device Name
TOP WHOLESOME FACE MASK
Manufacturer
Date Cleared
1999-04-09
(122 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
TOP WHOLESOME ENTERPRISE CO., 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 operating room personnel from transfer of micro-organisms, body fluids and particulate material.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1