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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K093661
Device Name COLONRING
Applicant
Niti Surgical Solutions, Ltd.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact JONATHAN KAHAN
Correspondent
Niti Surgical Solutions, Ltd.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact JONATHAN KAHAN
Regulation Number878.4300
Classification Product Code
FZP  
Date Received11/25/2009
Decision Date 02/10/2011
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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