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FDA 510(k) Application Details - K073705
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K073705
Device Name
Needle, Hypodermic, Single Lumen
Applicant
SHANDONG QIAOPAI GROUP CO., LTD
No.13,Qinghe Road,Gaoqing County
Zibo 256300 CN
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Contact
MARK JOB
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Regulation Number
880.5570
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Classification Product Code
FMI
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More FDA Info for this Product Code
Date Received
12/31/2007
Decision Date
03/24/2008
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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