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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 K062307
Device Name XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS
Applicant
ANULEX TECHNOLOGIES, INC
5600 ROWLAND ROAD, STE 280
MINNETONKA,  MN  55343
Applicant Contact TIMOTHY MILLER
Correspondent
ANULEX TECHNOLOGIES, INC
5600 ROWLAND ROAD, STE 280
MINNETONKA,  MN  55343
Correspondent Contact TIMOTHY MILLER
Regulation Number878.5000
Classification Product Code
GAT  
Date Received08/08/2006
Decision Date 09/01/2006
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
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