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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, Polyamide
510(k) Number K192420
Device Name Crownjun Nylon Suture
Applicant
Kono Seisakusho Co., Ltd.
3-43-16, Hongo
Bunkyo-Ku,  JP 130-0033
Applicant Contact Hiroyuki Arai
Correspondent
Ken Block Consulting
800 E. Campbell Dr., Suite 202
Richardson,  TX  75081
Correspondent Contact Akiko Dohi
Regulation Number878.5020
Classification Product Code
GAR  
Date Received09/04/2019
Decision Date 05/29/2020
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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