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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 K173779
Device Name REXMONO, PDREX
Applicant
Sm Eng Co., Ltd.
46, Nakdong-Daero 1302beon-Gil
Sasang-Gu,  KR 46910
Applicant Contact Soon-Gu Lee
Correspondent
Wise Company, Inc.
#1005, 11-19, Gamasan-Ro 27a-Gil
Guro-Gu,  KR 08301
Correspondent Contact Sanglok Lee
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Code
NEW  
Date Received12/12/2017
Decision Date 03/12/2018
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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