FDA 510(k) Application Details - K963506

Device Classification Name Table, Operating-Room, Ac-Powered

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510(K) Number K963506
Device Name Table, Operating-Room, Ac-Powered
Applicant TENET MEDICAL ENGINEERING
3553 31ST ST., N.W.
CALGARY T2L 2K7 CA
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Contact KEN MOORE
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Regulation Number 878.4960

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Classification Product Code FQO
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Date Received 09/03/1996
Decision Date 01/09/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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