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FDA 510(k) Application Details - K203191
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K203191
Device Name
Polymer Patient Examination Glove
Applicant
Nathan Trading Co., Ltd
58 Moo 12 Palan Sub-District
Nathan District 34170 TH
Other 510(k) Applications for this Company
Contact
Chansamone Saiyasak
Other 510(k) Applications for this Contact
Regulation Number
880.6250
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Classification Product Code
LZA
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More FDA Info for this Product Code
Date Received
10/27/2020
Decision Date
02/12/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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