FDA 510(k) Application Details - K963505

Device Classification Name Table, Obstetrical, Manual (And Accessories)

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510(K) Number K963505
Device Name Table, Obstetrical, Manual (And Accessories)
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 884.4900

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Classification Product Code HHP
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Date Received 09/03/1996
Decision Date 02/14/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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