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FDA 510(k) Application Details - K101366
Device Classification Name
Massager, Vacuum, Light Induced Heating
More FDA Info for this Device
510(K) Number
K101366
Device Name
Massager, Vacuum, Light Induced Heating
Applicant
CHROMOGENEX TECHNOLOGIES LTD
UNITS 1&2 HEOL RHOSYN,
PARC DAFEN
LLANELLI, CARMARTHENSHIRE SA148QG GB
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Contact
PETER R BEVAN
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
NUV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/17/2010
Decision Date
09/17/2010
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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