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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K183183
Device Name VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture
Applicant
Ethicon, Inc.
Route 22 W.
P.O. Box 151
Somerville,  NJ  08876
Applicant Contact Stephanie Saati
Correspondent
Ethicon, Inc.
Route 22 W.
P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact Stephanie Saati
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Code
NEW  
Date Received11/19/2018
Decision Date 06/27/2019
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 Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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