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510(k) K183236

Rotium Bioresorbable Wick by Nanofiber Solutions, LLC — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2019
Date Received
November 20, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Nanofiber Solutions, LLC

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  • K231641 — Rotium Bioresorbable Wick (July 5, 2023)
  • K201414 — Rotium Bioresorbable Wick (June 25, 2020)
  • K173544 — Phoenix Wound Matrix (March 2, 2018)

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