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510(k) K192616

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2019
Date Received
September 23, 2019
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)
  • K182255 — CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Ne (November 15, 2018)
  • K173242 — CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large) (October 25, 2017)

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