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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 K955364
Device Name SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
Applicant
W.L. GORE & ASSOCIATES,INC
3750 west kiltie ln.
p. o. box 500
flagstaff,  AZ  86002 -0500
Applicant Contact r. larry pratt
Correspondent
W.L. GORE & ASSOCIATES,INC
3750 west kiltie ln.
p. o. box 500
flagstaff,  AZ  86002 -0500
Correspodent Contact r. larry pratt
Regulation Number878.3300
Classification Product Code
OXD  
Subsequent Product Code
FTL  
Date Received11/22/1995
Decision Date 02/01/1996
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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