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FDA 510(k) Application Details - K071886
Device Classification Name
Wrap, Sterilization
More FDA Info for this Device
510(K) Number
K071886
Device Name
Wrap, Sterilization
Applicant
SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD.
1558-1-2101 SOUTH XIZANG ROAD
SHANGHAI 200011 CN
Other 510(k) Applications for this Company
Contact
LONGFU SONG
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
FRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/09/2007
Decision Date
12/27/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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