FDA 510(k) Application Details - K093455

Device Classification Name Computer, Diagnostic, Programmable

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510(K) Number K093455
Device Name Computer, Diagnostic, Programmable
Applicant BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD.
DIAMOND BAR, CA 91765 US
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Contact Balaka Das
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Regulation Number 870.1425

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Classification Product Code DQK
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Date Received 11/05/2009
Decision Date 12/04/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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