FDA 510(k) Application Details - K111501

Device Classification Name

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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
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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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