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510(k) K152050

Pencylcap by B.Braun Melsungen AG — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2016
Date Received
July 23, 2015
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

Other clearances by B.Braun Melsungen AG

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

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