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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 K061386
Device Name ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB
Applicant
ANULEX TECHNOLOGIES, INC
5600 ROWLAND ROAD, STE 280
MINNETONKA,  MN  55343
Applicant Contact TIM MILLER
Correspondent
ANULEX TECHNOLOGIES, INC
5600 ROWLAND ROAD, STE 280
MINNETONKA,  MN  55343
Correspondent Contact TIM MILLER
Regulation Number878.5000
Classification Product Code
GAT  
Date Received05/18/2006
Decision Date 07/05/2006
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
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