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FDA 510(k) Application Details - K012406
Device Classification Name
Apparatus, Autotransfusion
More FDA Info for this Device
510(K) Number
K012406
Device Name
Apparatus, Autotransfusion
Applicant
INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE, CA 92618-2402 US
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Contact
PROISE REY-FESSLER
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
07/30/2001
Decision Date
03/26/2002
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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