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FDA 510(k) Application Details - K063334
Device Classification Name
Respirator,Surgical
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510(K) Number
K063334
Device Name
Respirator,Surgical
Applicant
SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD.
7380 36TH COURT
VERO BEACH, FL 32967 US
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Contact
JOSEPH Z ZDROK
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
11/06/2006
Decision Date
12/08/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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