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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K201930
Device Name Nanum Syringe
Applicant
Nanum Company Co., Ltd.
4th Floor, 40, Siji-Ro
Daegu,  KR 42251
Applicant Contact Jeong Ung Jong
Correspondent
Plusglobal
300, Atwood St.
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/10/2020
Decision Date 01/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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