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FDA 510(k) Application Details - K980127
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K980127
Device Name
Set, Administration, Intravascular
Applicant
CATHETER INNOVATIONS, INC.
3598 WEST 1820 SOUTH
SALT LAKE CITY, UT 84104 US
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Contact
ROGER L RICHINS
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
FPA
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More FDA Info for this Product Code
Date Received
01/14/1998
Decision Date
03/11/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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