FDA 510(k) Application Details - K171387

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K171387
Device Name Stimulator, Muscle, Powered
Applicant Elite Medical Supply of New York, LLC
1900 Ridge Rd. Suite #125
West Seneca, NY 14224 US
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Contact John McGrady
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 05/11/2017
Decision Date 05/31/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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