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FDA 510(k) Application Details - K192533
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
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510(K) Number
K192533
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
Health Line International Corporation
5675 W 300 S
Salt Lake City, UT 84117 US
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Contact
Joel K. Faulkner
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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
09/16/2019
Decision Date
12/10/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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