FDA 510(k) Application Details - K152416

Device Classification Name

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510(K) Number K152416
Device Name Indego
Applicant PARKER HANNIFIN CORPORATION
1390 E. HIGHLAND ROAD
MACEDONIA, OH 44056 US
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Contact ACHILLEAS DOROTHEOU
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Regulation Number

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Classification Product Code PHL
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Date Received 08/26/2015
Decision Date 02/26/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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