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FDA 510(k) Application Details - K974617
Device Classification Name
Dilator, Vessel, For Percutaneous Catheterization
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510(K) Number
K974617
Device Name
Dilator, Vessel, For Percutaneous Catheterization
Applicant
ENDOVASCULAR INSTRUMENTS, INC.
1800 EAST 900 SOUTH
SALTLAKE CITY, UT 84108 US
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Contact
JACK SPEER
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Regulation Number
870.1310
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Classification Product Code
DRE
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More FDA Info for this Product Code
Date Received
12/11/1997
Decision Date
12/01/1998
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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