FDA 510(k) Application Details - K080950

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K080950
Device Name Stimulator, Muscle, Powered
Applicant OTTO BOCK, AUSTRIA GMBH
2247 JENNIFER LANE
NORTH ST. PAUL, MN 55109-2851 US
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Contact WILLIAM F JACKSON
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 04/03/2008
Decision Date 04/02/2009
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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