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FDA 510(k) Application Details - K210864
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K210864
Device Name
Needle, Hypodermic, Single Lumen
Applicant
Sandstone Medical (Suzhou) Inc.
No.168 PuTuoShan Road, New District
Suzhou 215153 CN
Other 510(k) Applications for this Company
Contact
Juanjuan Sun
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
03/23/2021
Decision Date
02/17/2022
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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