FDA 510(k) Application Details - K942685

Device Classification Name Display, Cathode-Ray Tube, Medical

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510(K) Number K942685
Device Name Display, Cathode-Ray Tube, Medical
Applicant MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
MILWAUKEE, WI 53224 US
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Contact LARRY A LEPLEY
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Regulation Number 870.2450

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Classification Product Code DXJ
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Date Received 06/07/1994
Decision Date 08/12/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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