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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, Silk
510(k) Number K024091
Device Name SILK SUTURES
Applicant
Aurolab
6441 Enterprise Ln.
Suite 214
Madison,  WI  53719
Applicant Contact MICHAEL G PRICE
Correspondent
Aurolab
6441 Enterprise Ln.
Suite 214
Madison,  WI  53719
Correspondent Contact MICHAEL G PRICE
Regulation Number878.5030
Classification Product Code
GAP  
Date Received12/11/2002
Decision Date 02/28/2003
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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