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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 K153611
Device Name Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
Applicant
Ethicon, LLC
475 C St.
Los Frailes Industrial Park, Suite 401,  PR  00969
Applicant Contact Marjorie Medina
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact Rubina Dosani
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Codes
GAT   OCW  
Date Received12/17/2015
Decision Date 06/03/2016
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
Predetermined Change
Control Plan Authorized		 No
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