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FDA 510(k) Application Details - K200425
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K200425
Device Name
Set, Administration, Intravascular
Applicant
MedSafety Solutions LLC
7012 S. Revere Pkwy, Suite 120
Centennial, CO 80112 US
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Contact
Rich Weiskopf
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/20/2020
Decision Date
10/29/2020
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
Y
Expedited Review
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