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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
Other 510(k) Applications for this Contact
Regulation Number
892.5770
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Classification Product Code
JAI
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More FDA Info for this Product Code
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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