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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K153087
Device Name IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved
Applicant
Ivy Sports Medicine, LLC
545 Penobscot Dr.
Redwood City,  CA  94063
Applicant Contact John Dichiara
Correspondent
Ivy Sports Medicine, LLC
545 Penobscot Dr.
Redwood City,  CA  94063
Correspondent Contact John Dichiara
Regulation Number878.5000
Classification Product Code
GAT  
Date Received10/26/2015
Decision Date 07/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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