FDA 510(k) Application Details - K013630

Device Classification Name System, Image Processing, Radiological

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510(K) Number K013630
Device Name System, Image Processing, Radiological
Applicant STENTOR, INC.
16303 PANORAMIC WAY
SAN LEANDRO, CA 94578 US
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Contact GARY J ALLSEBROOK
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 11/05/2001
Decision Date 12/05/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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