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FDA 510(k) Application Details - K110878

Device Classification Name Computer, Diagnostic, Programmable

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510(K) Number K110878
Device Name Computer, Diagnostic, Programmable
Applicant TOPERA, INC.
11445 E. VIA LINDA
SUITE 2, P.O. BOX 224
SCOTTSDALE, AZ US
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Contact RUCHIR SEHRA
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Regulation Number 870.1425

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Classification Product Code DQK
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Date Received 03/30/2011
Decision Date 09/23/2011
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review N



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