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 System, Peritoneal, Automatic Delivery
510(k) Number K102936
Device Name HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
Applicant
Baxter Healthcare Corp
1620 Waukegan Rd.
Mcgaw Park,  IL  60085
Applicant Contact DAVID E CURTIN
Correspondent
Baxter Healthcare Corp
1620 Waukegan Rd.
Mcgaw Park,  IL  60085
Correspondent Contact DAVID E CURTIN
Regulation Number876.5630
Classification Product Code
FKX  
Date Received10/04/2010
Decision Date 03/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-