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FDA 510(k) Application Details - K141640
Device Classification Name
Syringe, Antistick
More FDA Info for this Device
510(K) Number
K141640
Device Name
Syringe, Antistick
Applicant
SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD.
570 SILVERADO DRIVE
LAFAYETTE, CA 94549 US
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Contact
CHARMAINE HENDERSON
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Regulation Number
880.5860
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Classification Product Code
MEG
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More FDA Info for this Product Code
Date Received
06/19/2014
Decision Date
11/19/2014
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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