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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 K980155
Device Name ENDOBUTTON CONTINUOUS LOOP
Applicant
SMITH & NEPHEW, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Applicant Contact DEMETRIOS TSAKONAS
Correspondent
SMITH & NEPHEW, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Correspondent Contact DEMETRIOS TSAKONAS
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
MBI  
Date Received01/16/1998
Decision Date 04/01/1998
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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