510(k) K080077

CLAVE STOPCOCK by Icu Medical, Inc. — Product Code FMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2008
Date Received
January 11, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stopcock, I.V. Set
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type