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510(k) K160629

InPen by Companion Medical, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2016
Date Received
March 7, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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  • K181327 — InPen Dose Calculator (July 6, 2018)

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