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FDA 510(k) Application Details - K172357
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K172357
Device Name
Vinyl Patient Examination Glove
Applicant
EVER GROWTH (VIETNAM) CO., LTD
Long Khanh Industrial Zone,
Binh Loc Ward
Long Khanh Township 810000 VN
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Contact
Che-Min Lee
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/03/2017
Decision Date
12/29/2017
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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