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FDA 510(k) Application Details - K192444
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K192444
Device Name
Polymer Patient Examination Glove
Applicant
Mercator Medical (Thailand) LTD.
88/8 Moo 12 Tambon Kampaengphet
Amphur Rattaphum 90180 TH
Other 510(k) Applications for this Company
Contact
Praneet Inthajak
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/06/2019
Decision Date
12/31/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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