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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, steel, monofilament and multifilament, sterile
510(k) Number K170767
Device Name Surgical Stainless Steel Suture, Stainless Steel Suture
Applicant
Ethicon, Inc.
P.O. Box 151
Route 22 West
Somerville,  NJ  08876 -0151
Applicant Contact Hrishikesh Khatav
Correspondent
Ethicon, Inc.
P.O. Box 151
Route 22 West
Somerville,  NJ  08876 -0151
Correspondent Contact Hrishikesh Khatav
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received03/14/2017
Decision Date 11/01/2017
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
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