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FDA 510(k) Application Details - K163126
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K163126
Device Name
Polymer Patient Examination Glove
Applicant
Blue Sail Medical Co., Ltd
No. 21 Qingtian Road
Qilu Chemical Industrial Park
Zibo 255414 CN
Other 510(k) Applications for this Company
Contact
Robin Liu
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
11/08/2016
Decision Date
02/22/2017
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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