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510(k) K173242

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2017
Date Received
October 6, 2017
Clearance Type
Special
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.

  • K201313 — CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large) (June 15, 2020)
  • K192616 — CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large) (October 21, 2019)
  • K182255 — CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Ne (November 15, 2018)

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