510(k) K974083

CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS by Ohmeda Medical — Product Code FMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1998
Date Received
October 29, 1997
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