FDA 510(k) Application Details - K964782

Device Classification Name Stand, Infusion

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510(K) Number K964782
Device Name Stand, Infusion
Applicant MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA, PA 15051 US
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Contact SANDRA A PAVLOVIC
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Regulation Number 880.6990

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Classification Product Code FOX
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Date Received 11/27/1996
Decision Date 02/25/1997
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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