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510(k) K131040

EXTAVIPRO STERICAN 30G by B.Braun Melsungen AG — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2013
Date Received
April 15, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

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  • K102033 — COMBITRANS MONITORING SETS AND ACCESSORIES (April 7, 2011)

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