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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name retention device, suture
510(k) Number K020480
Device Name RBM
Applicant
SMITH & NEPHEW, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Applicant Contact WILLIAM MCCALLUM
Correspondent
SMITH & NEPHEW, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Correspondent Contact WILLIAM MCCALLUM
Regulation Number878.4930
Classification Product Code
KGS  
Date Received02/13/2002
Decision Date 03/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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