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Found 3 results
510(k) Data Aggregation
K Number
K970988Device Name
FAR-EAST BOUFFANT CAPS
Manufacturer
FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
Date Cleared
1997-07-10
(114 days)
Product Code
LYU
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
**FAR EAST SCIENCE **& TECHNOLOGY DEVELOPMENT CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Far-East Bouffant Caps are disposable devices, intended for medical purposes, that are worn by operating room personnel during surgical procedures to protect form surgical patient and operating room personnel from Burgioal patient and open commons and particulate materials.
Device Description
Far-East Bouffant Caps are disposable devices, intended for medical purposes, that are worn by operating room personnel during surgical procedures to protect form surgical patient and operating room personnel from Burgioal patient and open commons and particulate materials.
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K Number
K971191Device Name
FAR-EAST SHOE COVERS
Manufacturer
FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
Date Cleared
1997-07-10
(101 days)
Product Code
FXP
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
**FAR EAST SCIENCE **& TECHNOLOGY DEVELOPMENT CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Far-East Shoe Covers are disposable and single used devices, intended for medical purposes, that are worn on to cover the shoes of all personnel during the general medical procedures, or surgical procedures to protect the medical personnel, or surgical personnel from transfer of bacteria, micro-organisms and particulate material.
Device Description
Far-East Shoe Covers are disposable and single used devices, intended for medical purposes, that are worn on to cover the shoes of all personnel during the general medical procedures, or surgical procedures to protect the medical personnel, or surgical personnel from transfer of bacteria, micro-organisms and particulate material.
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K Number
K971702Device Name
FAR-EAST BARRIER GOWNS
Manufacturer
FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
Date Cleared
1997-07-08
(61 days)
Product Code
FYC, DAT
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
**FAR EAST SCIENCE **& TECHNOLOGY DEVELOPMENT CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Isolation for Far-East Barrier Gowns
Far-East Barrier Gowns are disposable and single use devices, for general medical purposes, that are worn on to intended protect the isolation patients, medical staffs and visitors from transfer of micro-organisms, body fluids and particulate material during the general medical procedures and patient room visits in hospitals. These devices are non-sterile, not intended to be used by O. R. personnel for surgical procedures.
Device Description
Far-East Barrier Gowns are disposable and single use devices, for general medical purposes, that are worn on to intended protect the isolation patients, medical staffs and visitors from transfer of micro-organisms, body fluids and particulate material during the general medical procedures and patient room visits in hospitals. These devices are non-sterile, not intended to be used by O. R. personnel for surgical procedures.
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