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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, Polyethylene
510(k) Number K033718
Device Name MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE
Applicant
Arthrotek, Inc.
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
Arthrotek, Inc.
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number878.5000
Classification Product Code
GAT  
Date Received11/26/2003
Decision Date 02/12/2004
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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