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FDA 510(k) Application Details - K111501
Device Classification Name
More FDA Info for this Device
510(K) Number
K111501
Device Name
I-LIPO SYSTEM
Applicant
CHROMOGENEX TECHNOLOGIES LIMITED
UNITS 1& 2 HEOL RHOSYN
PARC DAFEN INDUSTRIAL ESTATE
LLANELLI, CARMARTHENSHIRE SA14 8QG GB
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Contact
PETER R BEVAN
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Regulation Number
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Classification Product Code
OLI
Other 510(k) Applications for this Device
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Date Received
05/31/2011
Decision Date
03/23/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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