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, dialysate delivery, single patient
510(k) Number K781405
Device Name SUITCASE KIDNEY HEMODIALYSIS SYSTEM
Applicant
UNION CARBIDE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
UNION CARBIDE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5820
Classification Product Code
FKP  
Date Received08/14/1978
Decision Date 12/07/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-