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510(k) K182255

CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) by Aziyo Biologics, Inc. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2018
Date Received
August 20, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by Aziyo Biologics, Inc.

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  • K192616 — CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large) (October 21, 2019)
  • K173242 — CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large) (October 25, 2017)

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