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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, Polyester
510(k) Number K002261
Device Name MR-III
Applicant
Smith & Nephew, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Applicant Contact DEMETRIOS TSAKONAS
Correspondent
Smith & Nephew, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Correspondent Contact DEMETRIOS TSAKONAS
Regulation Number878.5000
Classification Product Code
GAS  
Date Received07/25/2000
Decision Date 10/23/2000
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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