FDA 510(k) Application Details - K072252

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K072252
Device Name Stimulator, Muscle, Powered
Applicant ADREM TECHNOLOGY SARL
9109 COPENHAVER DRIVE
POTOMAC, MD 20854 US
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Contact NORMAN F ESTRIN
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 08/13/2007
Decision Date 01/30/2008
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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