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FDA 510(k) Application Details - K200263
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
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510(K) Number
K200263
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
Health Line International Corporation
5675 W 300 S
Salt Lake City, UT 84104 US
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Contact
Aaron G Faulkner
Other 510(k) Applications for this Contact
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
02/03/2020
Decision Date
03/12/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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