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FDA 510(k) Application Details - K170575
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K170575
Device Name
Vinyl Patient Examination Glove
Applicant
Ever Global (Vietnam) Enterprise Corp
Long Thanh Industrial Zone
Taman Village
Dong Nai Province 810000 VN
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Contact
Jerry Lin
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
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More FDA Info for this Product Code
Date Received
02/27/2017
Decision Date
05/16/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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