FDA 510(k) Application Details - K051013

Device Classification Name Equipment, Traction, Powered

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510(K) Number K051013
Device Name Equipment, Traction, Powered
Applicant CERT HEALTH SCIENCES, LLC
10440 LITTLE PATUXENT PARKWAY
SUITE 300
COLUMBIA, MD 21044 US
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Contact TIM R EMSKY
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Regulation Number 890.5900

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Classification Product Code ITH
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Date Received 04/21/2005
Decision Date 04/27/2005
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 Y
Expedited Review



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