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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 K173242
Device Name CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)
Applicant
Aziyo Biologics, Inc.
1100 Old Ellis Road, Suite 1200
Roswell,  GA  30076
Applicant Contact Wendy Perreault
Correspondent
Aziyo Biologics, Inc.
1100 Old Ellis Road, Suite 1200
Roswell,  GA  30076
Correspondent Contact Wendy Perreault
Regulation Number878.3300
Classification Product Code
FTM  
Date Received10/06/2017
Decision Date 10/25/2017
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
Recalls CDRH Recalls
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