FDA 510(k) Application Details - K963098

Device Classification Name Apparatus, Autotransfusion

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510(K) Number K963098
Device Name Apparatus, Autotransfusion
Applicant DEKNATEL, INC.
600 AIRPORT RD.
FALL RIVER, MA 02720 US
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Contact DEAN E CIPORKIN
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Regulation Number 868.5830

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Classification Product Code CAC
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Date Received 08/09/1996
Decision Date 11/08/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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