FDA 510(k) Application Details - K952108

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K952108
Device Name Accelerator, Linear, Medical
Applicant MITSUBISHI INTL. CORP.
TWO TOWER BRIDGE
1 FAYETTE STREET, SUITE 100
CONSHOHOCKEN, PA US
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Contact HIDEYUKI (HIRO) KAWAKAMI
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 05/05/1995
Decision Date 12/21/1995
Decision SE - Substantially Equivalent
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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