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 Container, I.V.
510(k) Number K844664
Device Name THE I.V. BAG
Applicant
Kabivitrum, Inc.
P.O. Box 1550
Berkeley,  CA  94701
Applicant Contact RONALD G LEONARDI
Correspondent
Kabivitrum, Inc.
P.O. Box 1550
Berkeley,  CA  94701
Correspondent Contact RONALD G LEONARDI
Regulation Number880.5025
Classification Product Code
KPE  
Date Received11/30/1984
Decision Date 05/06/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-