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FDA 510(k) Application Details - K955801
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K955801
Device Name
Wire, Guide, Catheter
Applicant
TERUMO MEDICAL CORP.
125 BLUE BALL RD.
ELKTON, MD 21921 US
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Contact
KEITH M SMITH
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
12/22/1995
Decision Date
02/02/1996
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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