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FDA 510(k) Application Details - K093431
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K093431
Device Name
Catheter, Percutaneous
Applicant
ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON, NH 03051 US
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Contact
RAYMOND KELLY
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
11/04/2009
Decision Date
04/20/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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