FDA 510(k) Application Details - K993675

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K993675
Device Name System,Planning,Radiation Therapy Treatment
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 892.5050

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Classification Product Code MUJ
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Date Received 11/01/1999
Decision Date 09/05/2000
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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