FDA 510(k) Application Details - K170502

Device Classification Name Couch, Radiation Therapy, Powered

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510(K) Number K170502
Device Name Couch, Radiation Therapy, Powered
Applicant Forte Automation Systems, Inc.
8155 Burden Rd
Machesney Park, IL 61115 US
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Contact Phil Reece
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Regulation Number 892.5770

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Classification Product Code JAI
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Date Received 02/21/2017
Decision Date 04/13/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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