FDA 510(k) Application Details - K952314

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K952314
Device Name Accelerator, Linear, Medical
Applicant MITSUBISHI INTL. CORP.
TWO TOWER BRIDGE
1 FAYETTE STREET, SUITE 100
CONSHOHOCKEN, PA 19428 US
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Contact HIDEYUIKI H KAWAKAMI
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 05/17/1995
Decision Date 01/17/1996
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



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