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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 K001789
Device Name SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
Applicant
W.L. GORE & ASSOCIATES,INC
3450 west kiltie ln.
flagstaff,,  AZ  86002
Contact r. larry pratt
Regulation Number878.3300
Classification Product Code
OXD  
Date Received06/13/2000
Decision Date 07/06/2000
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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