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 Pump, Infusion
510(k) Number K910425
Device Name LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.
Applicant
Baxter Healthcare Corp
Route 120 And Wilson Rd.
Round Lake,  IL  60073
Applicant Contact PATRICIA S BARSANTI
Correspondent
Baxter Healthcare Corp
Route 120 And Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact PATRICIA S BARSANTI
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/31/1991
Decision Date 04/01/1991
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
Recalls CDRH Recalls
-
-