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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K201313
Device Name CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)
Applicant
Aziyo Biologics, Inc.
1100 Old Ellis Rd.
Suite 1200
Roswell,  GA  30076
Applicant Contact Wendy Perreault
Correspondent
Aziyo Biologics, Inc.
1100 Old Ellis Rd.
Suite 1200
Roswell,  GA  30076
Correspondent Contact Wendy Perreault
Regulation Number878.3300
Classification Product Code
FTM  
Date Received05/18/2020
Decision Date 06/15/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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