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FDA 510(k) Application Details - K191469
Device Classification Name
Stylet, Catheter
More FDA Info for this Device
510(K) Number
K191469
Device Name
Stylet, Catheter
Applicant
Biotronik, Inc
6024 Jean Road
Lake Oswego, OR 97035 US
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Contact
Jon Brumbaugh
Other 510(k) Applications for this Contact
Regulation Number
870.1380
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Classification Product Code
DRB
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More FDA Info for this Product Code
Date Received
06/03/2019
Decision Date
08/01/2019
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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