FDA 510(k) Application Details - K062237

Device Classification Name System, Image Processing, Radiological

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510(K) Number K062237
Device Name System, Image Processing, Radiological
Applicant SYNCA MARKETING, INC.
337 MARION STREET
LE GARDEUR, QUEBEC J5Z 4W8 CA
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Contact STEPHANE ARSENAULT
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 08/02/2006
Decision Date 11/20/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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