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FDA 510(k) Application Details - K191853
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K191853
Device Name
Needle, Hypodermic, Single Lumen
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
Bldg. 1, No. 12, Longtan Road, Cangqian Street
Yuhang District
Hangzhou City CN
Other 510(k) Applications for this Company
Contact
Zearou Yang
Other 510(k) Applications for this Contact
Regulation Number
880.5570
More FDA Info for this Regulation Number
Classification Product Code
FMI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/10/2019
Decision Date
09/05/2019
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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