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FDA 510(k) Application Details - K050575
Device Classification Name
Instrument, Manual, Surgical, General Use
More FDA Info for this Device
510(K) Number
K050575
Device Name
Instrument, Manual, Surgical, General Use
Applicant
FUTUMEDS SDN BHD
NO. 3, JALAN PUCHONG,
BATU 12 1/2
PUCHONG 47100 MY
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Contact
LEONG PEI PING
Other 510(k) Applications for this Contact
Regulation Number
878.4800
More FDA Info for this Regulation Number
Classification Product Code
MDM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/07/2005
Decision Date
08/15/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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