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510(k) K061143

ROBERTSITE STOPCOCK by Halkey-Roberts Corp. — Product Code FMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2006
Date Received
April 25, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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