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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 K073096
Device Name ANCHORAGE CLOSURE DEVICE
Applicant
EPITEK, INC.
4801 W. 81ST STREET
SUITE 105
BLOOMINGTON,  MN  55437
Applicant Contact WERNER HAMPL
Correspondent
EPITEK, INC.
4801 W. 81ST STREET
SUITE 105
BLOOMINGTON,  MN  55437
Correspondent Contact WERNER HAMPL
Regulation Number878.5000
Classification Product Code
GAT  
Date Received11/01/2007
Decision Date 02/07/2008
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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