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FDA 510(k) Application Details - K193555
Device Classification Name
Patient Examination Glove, Specialty
More FDA Info for this Device
510(K) Number
K193555
Device Name
Patient Examination Glove, Specialty
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
LZC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/20/2019
Decision Date
06/04/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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