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FDA 510(k) Application Details - K954457
Device Classification Name
Catheter, Continuous Flush
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510(K) Number
K954457
Device Name
Catheter, Continuous Flush
Applicant
MEDI-TECH, INC.
One Boston Scientific Place
Natick, MA 01760 US
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DARLENE A THOMETZ
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Regulation Number
870.1210
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Classification Product Code
KRA
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Date Received
09/25/1995
Decision Date
05/15/1996
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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