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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 K160564
Device Name TroClose1200
Applicant
Gordian Surgical, Ltd.
17th Tchelet St.
Karmiel,  IL 2161401
Applicant Contact ZVI PEER
Correspondent
Dr. Susan Alpert
200 Park Ave., Unit 111
Minneapolis,  MN  55415
Correspondent Contact SUSAN ALPERT
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Code
GCJ  
Date Received02/29/2016
Decision Date 11/17/2016
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
Recalls CDRH Recalls
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