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510(k) K201313

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2020
Date Received
May 18, 2020
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.

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

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