FDA 510(k) Application Details - K062817

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K062817
Device Name Accelerator, Linear, Medical
Applicant PTW-NEW YORK CORP.
205 PARK AVE.
HICKSVILLE, NY 11801 US
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Contact RICHARD D BARKER
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 09/20/2006
Decision Date 11/22/2006
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

FDA Source Information for K062817


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