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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, non-absorbable, staple line reinforcement
510(k) Number K010936
Device Name MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
Original Applicant
W.L. GORE & ASSOCIATES,INC
3450 west kiltie ln.
flagstaff,,  AZ  86002
Original Contact r. larry pratt
Regulation Number878.3300
Classification Product Code
OXD  
Date Received03/28/2001
Decision Date 05/21/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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