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FDA 510(k) Application Details - K063695
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K063695
Device Name
Wire, Guide, Catheter
Applicant
TERUMO MEDICAL CORP.
950 Elkton Blvd.
Elkton, MD 21921 US
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Contact
MARK UNTERREINER
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/13/2006
Decision Date
04/27/2007
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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