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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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