• 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 set, administration, intravascular
510(k) Number K112204
Device Name KDL DISPOSABLE INFUSION SET
Applicant
SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD.
P.O. BOX 237-023
SHANGHAI,  CN 200237
Applicant Contact Diana Hong
Correspondent
SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD.
P.O. BOX 237-023
SHANGHAI,  CN 200237
Correspondent Contact Diana Hong
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/01/2011
Decision Date 09/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-