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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K050384
Device Name KAPP BARI-RING, MODEL KS-BR-2005
Applicant
Kapp Surgical Instrument, Inc.
4919 Warrensville Center Rd.
Warrensville,  OH  44128
Applicant Contact ALBERT SANTILLI
Correspondent
Kapp Surgical Instrument, Inc.
4919 Warrensville Center Rd.
Warrensville,  OH  44128
Correspondent Contact ALBERT SANTILLI
Regulation Number878.4300
Classification Product Code
NEU  
Date Received02/15/2005
Decision Date 01/13/2006
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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