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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
510(k) Number K863034
Device Name SHARPOINT STAINLESS STEEL SUTURE
Applicant
Chathamborough Research Group, Inc.
105 W. St.
P.O. Box Drawer 929
Pittsboro,  NC  27312
Applicant Contact TIM HUBBARD
Correspondent
Chathamborough Research Group, Inc.
105 W. St.
P.O. Box Drawer 929
Pittsboro,  NC  27312
Correspondent Contact TIM HUBBARD
Regulation Number878.4495
Classification Product Code
GAO  
Date Received08/11/1986
Decision Date 09/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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