FDA 510(k) Application Details - K964519

Device Classification Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered

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510(K) Number K964519
Device Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Applicant KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
15 HAMPSHIRE ST.
MANSFIELD, MA 02048 US
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Contact DAVID A OLSON
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Regulation Number 880.6740

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Classification Product Code GCX
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Date Received 11/12/1996
Decision Date 12/20/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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