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FDA 510(k) Application Details - K050276
Device Classification Name
More FDA Info for this Device
510(K) Number
K050276
Device Name
DIVER C.E. CATHETER
Applicant
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
4600 Nathan Lane North
Plymouth, MN 55442 US
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Contact
PATRICE STROMBERG
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Regulation Number
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Classification Product Code
QEZ
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Date Received
02/07/2005
Decision Date
03/07/2005
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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