FDA 510(k) Application Details - K014022

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K014022
Device Name Accelerator, Linear, Medical
Applicant I.Z.I. CORP.
7020 TUDSBURY RD.
BALTIMORE, MD 21244 US
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Contact HELEN ZINREICH
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 12/06/2001
Decision Date 03/04/2002
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



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