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FDA 510(k) Application Details - K162917
Device Classification Name
System, Delivery, Allergen And Vaccine
More FDA Info for this Device
510(K) Number
K162917
Device Name
System, Delivery, Allergen And Vaccine
Applicant
PROCARE INDUSTRIAL CO., LIMITED
NO.5-2-9-160, SCIENCE AVENUE 89
HI-TECH ZONE
ZHENGZHOU 450000 CN
Other 510(k) Applications for this Company
Contact
WANG YANHONG
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LDH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/18/2016
Decision Date
08/17/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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