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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 K964935
Device Name SUTURE LOCK
Applicant
SMITH & NEPHEW ENDOSCOPY, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Applicant Contact SUSAN A FINNERAN
Correspondent
SMITH & NEPHEW ENDOSCOPY, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Correspondent Contact SUSAN A FINNERAN
Regulation Number878.4930
Classification Product Code
KGS  
Subsequent Product Code
MBI  
Date Received12/10/1996
Decision Date 02/25/1997
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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