FDA 510(k) Application Details - K071596

Device Classification Name Massager, Powered Inflatable Tube

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510(K) Number K071596
Device Name Massager, Powered Inflatable Tube
Applicant NIHON SEIMITSU SOKKI CO., LTD.
3F, 2-17-6 AKEBONO-CHO
TACHIKAWA- SHI 190-0012 JP
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Contact KOJI KUBO
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Regulation Number 890.5650

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Classification Product Code IRP
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Date Received 06/12/2007
Decision Date 02/15/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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