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FDA 510(k) Application Details - K072067
Device Classification Name
Respirator,Surgical
More FDA Info for this Device
510(K) Number
K072067
Device Name
Respirator,Surgical
Applicant
SHUENN BAO SHING CORPORATION
NO. 58, FU CHIUN STREET
HSIN CHU CITY 30067 TW
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Contact
Ke-Min Jen
Other 510(k) Applications for this Contact
Regulation Number
878.4040
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Classification Product Code
MSH
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More FDA Info for this Product Code
Date Received
07/27/2007
Decision Date
01/08/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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