• 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, sorbent regenerated
510(k) Number K870270
Device Name MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART.
Applicant
ASH MEDICAL SYSTEMS, INC.
2701 B KENT AVE.
WEST LAFAYETTE,  IN  47906
Applicant Contact ASH, M.D.
Correspondent
ASH MEDICAL SYSTEMS, INC.
2701 B KENT AVE.
WEST LAFAYETTE,  IN  47906
Correspondent Contact ASH, M.D.
Regulation Number876.5600
Classification Product Code
FKT  
Date Received01/27/1987
Decision Date 02/25/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-