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FDA 510(k) Application Details - K181130
Device Classification Name
Patient Examination Glove, Specialty
More FDA Info for this Device
510(K) Number
K181130
Device Name
Patient Examination Glove, Specialty
Applicant
Hebei Titans Hongsen Medical Technology Co., LTD.
Eastern Industrial Zone
Nangong 051800 CN
Other 510(k) Applications for this Company
Contact
Shaozhang Nan
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
04/30/2018
Decision Date
08/10/2018
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
N
Expedited Review
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