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FDA 510(k) Application Details - K140205
Device Classification Name
Apparatus, Autotransfusion
More FDA Info for this Device
510(K) Number
K140205
Device Name
Apparatus, Autotransfusion
Applicant
Teleflex Medical, Inc.
2917 WECK DR.
PO BOX 12600
RESEARCH TRIANGLE PARK, NC 27709 US
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Contact
HOLLY KORNEGAY
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Regulation Number
868.5830
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Classification Product Code
CAC
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More FDA Info for this Product Code
Date Received
01/27/2014
Decision Date
10/23/2014
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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