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510(k) Data Aggregation
K Number
K971744Device Name
FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)
Manufacturer
Date Cleared
1997-07-28
(77 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
BERKLEY MEDICAL RESOURCES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BMR - 1501, 1503 Surgical Face Mask is a surgical apparel device that is intended to be worn by operating 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. The BMR - 1501, 1503 Surgical Face Mask is intended to be used in the above application as a single use disposable device.
Device Description
Surgical Face Mask, Code 1501, 1503
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K Number
K962286Device Name
2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD
Manufacturer
Date Cleared
1996-10-07
(115 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
BERKLEY MEDICAL RESOURCES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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