FDA 510(k) Application Details - K991546

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K991546
Device Name Accelerator, Linear, Medical
Applicant AKTINA MEDICAL PHYSICS CORP.
360 NORTH ROUTE 9W
CONGERS, NY 10920 US
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Contact JOAN ZACHAROPOULOS
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 05/03/1999
Decision Date 07/30/1999
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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