• 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 pump, infusion
510(k) Number K884014
Device Name FLO-GARD VP
Applicant
BAXTER HEALTHCARE CORP.
P.O. BOX 11150
SANTA ANA,  CA  92711
Applicant Contact NANCY E SHADFORTH
Correspondent
BAXTER HEALTHCARE CORP.
P.O. BOX 11150
SANTA ANA,  CA  92711
Correspondent Contact NANCY E SHADFORTH
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/22/1988
Decision Date 12/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-