FDA 510(k) Application Details - K942844

Device Classification Name Apparatus, Autotransfusion

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510(K) Number K942844
Device Name Apparatus, Autotransfusion
Applicant LEVEL 1 TECHNOLOGIES, INC.
160 WEYMOUTH ST.
ROCKLAND, MA 02370 US
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Contact WESLEY H VERKAART
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Regulation Number 868.5830

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Classification Product Code CAC
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Date Received 06/16/1994
Decision Date 04/26/1996
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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