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510(k) K191659

Instylla Delivery Kit by Instylla, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2019
Date Received
June 21, 2019
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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  • K200744 — Instylla Microcatheter (April 21, 2020)
  • K191731 — Instylla Microcatheter (August 13, 2019)

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