FDA 510(k) Application Details - K010472

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K010472
Device Name Accelerator, Linear, Medical
Applicant THOMSON & NIELSEN ELECTRONICS, LTD.
25B NORTHSIDE RD.
OTTAWA, ONTARIO K2H 8S1 CA
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Contact ANDREW HARTSHORN
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 02/20/2001
Decision Date 05/08/2001
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 N
Expedited Review



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