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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, Polyamide
510(k) Number K032160
Device Name ARTELON SURGICAL SUTURE
Applicant
Artimplant AB
719 A St. NE
Washington,  DC  20002
Applicant Contact RUSS PAGANO
Correspondent
Artimplant AB
719 A St. NE
Washington,  DC  20002
Correspondent Contact RUSS PAGANO
Regulation Number878.5020
Classification Product Code
GAR  
Date Received07/15/2003
Decision Date 11/17/2003
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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