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FDA 510(k) Application Details - K992664
Device Classification Name
Stylet, Catheter
More FDA Info for this Device
510(K) Number
K992664
Device Name
Stylet, Catheter
Applicant
TFX MEDICAL GROUP
TALL PINES PARK
JAFFREY, NH 03452 US
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Contact
JULIE A BEAUMONT
Other 510(k) Applications for this Contact
Regulation Number
870.1380
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Classification Product Code
DRB
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More FDA Info for this Product Code
Date Received
08/09/1999
Decision Date
04/13/2000
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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