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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 K970416
Device Name ACUFEX DOUBLE ARMED SUTURE NEEDLE
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 Number878.5000
Classification Product Code
GAT  
Date Received02/04/1997
Decision Date 04/21/1997
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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