Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-