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 Needle, Hypodermic, Single Lumen
510(k) Number K022057
Device Name KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX
Applicant
Kyung GI Medical Ind. Co., Ltd.
529-4 Yulsaeng-Ri Daegot-Myun
Kimpo-Si, Kyunggi-Do,  KR 4152367
Applicant Contact BYUNG DOO JEE
Correspondent
Kyung GI Medical Ind. Co., Ltd.
529-4 Yulsaeng-Ri Daegot-Myun
Kimpo-Si, Kyunggi-Do,  KR 4152367
Correspondent Contact BYUNG DOO JEE
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
FMF  
Date Received06/24/2002
Decision Date 11/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-