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FDA 510(k) Applications for Medical Device Product Code "OUH"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K101510
ENDYMED MEDICAL LTD
FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR
02/17/2011
K120513
ENDYMED MEDICAL LTD
GLOW BY ENDYMED
05/08/2012
K130501
ENDYMED MEDICAL LTD
INTENSIF
03/13/2014
K142833
JEISYS MEDICAL, INC.
INTRAGen
06/04/2015
K150409
Sung Hwan E&B Co.,Ltd
VIVACE Electrosurgical System
01/15/2016
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