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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
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