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FDA 510(k) Application Details - K981368
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
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510(K) Number
K981368
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
CATHETER INNOVATIONS, INC.
3598 WEST 1820 SOUTH
SALT LAKE CITY, UT 84104 US
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Contact
ROGER L RICHINS
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Regulation Number
880.5200
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Classification Product Code
FOZ
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More FDA Info for this Product Code
Date Received
04/15/1998
Decision Date
05/01/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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