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 Accessories, Blood Circuit, Hemodialysis
510(k) Number K972206
Device Name NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS
Applicant
Nipro Medical Corp.
1384 Copperfield Ct.
Lexington,  KY  40514
Applicant Contact KAELYN HADLEY
Correspondent
Nipro Medical Corp.
1384 Copperfield Ct.
Lexington,  KY  40514
Correspondent Contact KAELYN HADLEY
Regulation Number876.5820
Classification Product Code
KOC  
Date Received06/11/1997
Decision Date 11/26/1997
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
Predetermined Change
Control Plan Authorized		 No
-
-