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FDA 510(k) Application Details - K120953
Device Classification Name
Apparatus, Autotransfusion
More FDA Info for this Device
510(K) Number
K120953
Device Name
Apparatus, Autotransfusion
Applicant
TLELFLEX MEDICAL, INC.
2917 Weck Drive
Research Triangle Park, NC 27709 US
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Contact
LORRAINE DELONG
Other 510(k) Applications for this Contact
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
03/30/2012
Decision Date
12/10/2012
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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