FDA 510(k) Application Details - K002608

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K002608
Device Name Accelerator, Linear, Medical
Applicant DUNCAN HYND ASSOCIATES, LTD.
719 CATALPA AVE.
TEANECK, NJ 07666 US
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Contact DIANA UPTON
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 08/21/2000
Decision Date 11/16/2000
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

FDA Source Information for K002608


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