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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 K100572
Device Name VERSACLOSE, MODEL VC-200-01
Applicant
Anulex Technologies, Inc.
5600 Rowland Rd., Suite 280
Minnetonka,  MN  55343
Applicant Contact RACHEL KENNEDY
Correspondent
Anulex Technologies, Inc.
5600 Rowland Rd., Suite 280
Minnetonka,  MN  55343
Correspondent Contact RACHEL KENNEDY
Regulation Number878.5000
Classification Product Code
GAT  
Date Received03/01/2010
Decision Date 03/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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