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 Dialyzer, Capillary, Hollow Fiber
510(k) Number K952343
Device Name FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER
Applicant
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
2 VOLVO DR.
ROCKLEIGH,  NJ  07647
Applicant Contact DEBRA L BING
Correspondent
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
2 VOLVO DR.
ROCKLEIGH,  NJ  07647
Correspondent Contact DEBRA L BING
Regulation Number876.5820
Classification Product Code
FJI  
Subsequent Product Code
KDI  
Date Received05/19/1995
Decision Date 12/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-