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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 K180191
Device Name SuperBall Meniscal Repair System
Applicant
Arcuro Medical , Ltd.
17 Tchelet St.
Misgav,  IL 2017400
Applicant Contact Lee Ranon
Correspondent
Hogan Lovells US LLP
1735 Market St., Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number878.5000
Classification Product Code
GAT  
Date Received01/23/2018
Decision Date 06/05/2018
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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