FDA 510(k) Application Details - K021987

Device Classification Name Block, Beam-Shaping, Radiation Therapy

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510(K) Number K021987
Device Name Block, Beam-Shaping, Radiation Therapy
Applicant S&S PAR SCIENTIFIC
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 892.5710

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Classification Product Code IXI
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Date Received 06/18/2002
Decision Date 12/27/2002
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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