• 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 K032767
Device Name LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES
Applicant
LILY MEDICAL SUPPLIES CO., LTD.
NO. 58 FU-CHIUN ST.
HSIN-CHU CITY,  TW 300
Applicant Contact Ke-Min Jen
Correspondent
LILY MEDICAL SUPPLIES CO., LTD.
NO. 58 FU-CHIUN ST.
HSIN-CHU CITY,  TW 300
Correspondent Contact Ke-Min Jen
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/05/2003
Decision Date 06/03/2004
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
-
-