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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, Polypropylene
510(k) Number K904906
Device Name SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP
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 Number878.5010
Classification Product Code
GAW  
Date Received10/25/1990
Decision Date 12/24/1990
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
Recalls CDRH Recalls
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