FDA 510(k) Application Details - K990085

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K990085
Device Name Accelerator, Linear, Medical
Applicant VARIAN ASSOC., INC.
3045 HANOVER ST.
MAIL STOP H-055
PALO ALTO, CA 94304-1129 US
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Contact LINDA S NASH
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 01/11/1999
Decision Date 02/08/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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