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FDA 510(k) Application Details - K030135
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K030135
Device Name
Introducer, Catheter
Applicant
B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN, PA 18109-9341 US
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Contact
AMY K SMITH
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/14/2003
Decision Date
07/15/2003
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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