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FDA 510(k) Application Details - K052791
Device Classification Name
Catheter, Percutaneous
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510(K) Number
K052791
Device Name
Catheter, Percutaneous
Applicant
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
4600 Nathan Lane North
Plymouth, MN 55442 US
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Contact
STEPHANIE ROBINSON
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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
10/03/2005
Decision Date
11/04/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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