FDA 510(k) Application Details - K970857

Device Classification Name Apparatus, Autotransfusion

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510(K) Number K970857
Device Name Apparatus, Autotransfusion
Applicant DAVIS & GECK, INC.
1915 OLIVE ST.
ST. LOUIS, MO 63103 US
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Contact VANADA JOHNSON
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Regulation Number 868.5830

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Classification Product Code CAC
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Date Received 03/10/1997
Decision Date 11/05/1997
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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