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 K820743
Device Name HOLLOW FIBER DIALYZERS
Applicant
TERUMO MEDICAL CORP.
120 NEW ENGLAND AVENUE
PISCATAWAY,  NJ  08854 -
Applicant Contact DAVID MARSH
Correspondent
TERUMO MEDICAL CORP.
120 NEW ENGLAND AVENUE
PISCATAWAY,  NJ  08854 -
Correspondent Contact DAVID MARSH
Regulation Number876.5820
Classification Product Code
FJI  
Date Received03/19/1982
Decision Date 06/23/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-