FDA 510(k) Application Details - K960734

Device Classification Name Apparatus, Autotransfusion

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510(K) Number K960734
Device Name Apparatus, Autotransfusion
Applicant HAEMOCELL PLC
12 NAPIER COURT
BARTON LANE
ABINGDON, OXON, ENGLAND 0X14 3YT GB
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Contact R C HALL
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Regulation Number 868.5830

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Classification Product Code CAC
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Date Received 02/22/1996
Decision Date 12/10/1996
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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