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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 K182255
Device Name CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro 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 Received08/20/2018
Decision Date 11/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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