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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 K161629
Device Name CRYLREX
Applicant
SM ENG CO., LTD
46, NAKDONG-DAERO 1302BEON-GIL
SASANG-GU,  KR
Applicant Contact SOON-GU LEE
Correspondent
WISE COMPANY INC.
#306, 3 DAERIM-RO 27GA-GIL
YEONGDEUNGPO-GU,  KR 07413
Correspondent Contact SANGLOK LEE
Regulation Number878.4493
Classification Product Code
GAM  
Date Received06/13/2016
Decision Date 02/10/2017
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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