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FDA 510(k) Application Details - K980104
Device Classification Name
Catheter, Continuous Flush
More FDA Info for this Device
510(K) Number
K980104
Device Name
Catheter, Continuous Flush
Applicant
MICRO THERAPEUTICS, INC.
1062-F CALLE NEGOCIO
SAN CLEMENTE, CA 92673 US
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Contact
TOM DAUGHTERS
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Regulation Number
870.1210
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Classification Product Code
KRA
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More FDA Info for this Product Code
Date Received
01/12/1998
Decision Date
04/10/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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