FDA 510(k) Application Details - K160299

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K160299
Device Name Stimulator, Muscle, Powered
Applicant FIRSTKIND LIMITED
HAWK HOUSE
PEREGRINE BUSINESS PARK
HIGH WYCOMBE HP13 7DL GB
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Contact NEIL BUCKLEY
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 02/04/2016
Decision Date 04/08/2016
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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