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 K973291
Device Name DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES
Applicant
DYNAMIC TECHNOLOGY CORP.
6833 SAINT LAWRENCE ST.
PLANO,  TX  75024
Applicant Contact ERIC LUO
Correspondent
DYNAMIC TECHNOLOGY CORP.
6833 SAINT LAWRENCE ST.
PLANO,  TX  75024
Correspondent Contact ERIC LUO
Regulation Number876.5820
Classification Product Code
FJI  
Date Received09/02/1997
Decision Date 12/19/1997
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
-
-