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FDA 510(k) Application Details - K093479
Device Classification Name
System, Evacuator, Fluid
More FDA Info for this Device
510(K) Number
K093479
Device Name
System, Evacuator, Fluid
Applicant
MODERN MEDICAL EQUIPMENT MFG., LTD.
DONG XING INDUSTRIAL AREA
KANG LE LU, SHAN XIA DISTRICT
HENG LI, DONGGUAN, GUANGDONG 523466 CN
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Contact
EUGENE YEUNG
Other 510(k) Applications for this Contact
Regulation Number
876.4370
More FDA Info for this Regulation Number
Classification Product Code
FHF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/09/2009
Decision Date
05/19/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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