FDA 510(k) Application Details - K972016

Device Classification Name Block, Beam-Shaping, Radiation Therapy

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510(K) Number K972016
Device Name Block, Beam-Shaping, Radiation Therapy
Applicant C.L. MCINTOSH & ASSOC., INC.
12300 TWINBROOK PKWY.
SUITE 625
ROCKVILLE, MD 20852 US
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Contact T. WHIT ATHEY
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Regulation Number 892.5710

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Classification Product Code IXI
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Date Received 05/30/1997
Decision Date 12/04/1997
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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