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FDA 510(k) Application Details - K013036
Device Classification Name
Couch, Radiation Therapy, Powered
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510(K) Number
K013036
Device Name
Couch, Radiation Therapy, Powered
Applicant
NOMOS CORP.
2591 WEXFORD BAYNE RD.
SUITE 400
SEWICKLEY, PA 15143 US
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Contact
FRANCIS X DOBSCHA
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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
09/10/2001
Decision Date
12/07/2001
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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