FDA 510(k) Application Details - K150033

Device Classification Name Massager, Powered Inflatable Tube

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510(K) Number K150033
Device Name Massager, Powered Inflatable Tube
Applicant DAESUNG MAREF CO., LTD.
298-24, GONGDAN-RO
GUNPO-SHI 435-862 KR
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Contact JAE-WHA LEE
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Regulation Number 890.5650

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Classification Product Code IRP
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Date Received 01/09/2015
Decision Date 04/20/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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