FDA 510(k) Application Details - K033066

Device Classification Name

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510(K) Number K033066
Device Name XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
Applicant XITEC HOLDINGS LLC.
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact DANIEL J DILLON
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Regulation Number

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Classification Product Code OXO
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Date Received 09/29/2003
Decision Date 11/12/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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