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510(k) K040634

ROBERTSITE VIAL ADAPTER, MODEL 245700021 by Halkey-Roberts Corp. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2004
Date Received
March 10, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Halkey-Roberts Corp.

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