FDA 510(k) Application Details - K973162

Device Classification Name Monitor, Patient Position, Light-Beam

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510(K) Number K973162
Device Name Monitor, Patient Position, Light-Beam
Applicant HOGAN & HARTSON
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004-1109 US
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Contact HOWARD M HOLSTEIN
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Regulation Number 892.5780

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Classification Product Code IWE
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Date Received 08/22/1997
Decision Date 11/20/1997
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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