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 Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K851236
Device Name HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES
Applicant
Infarkem Corp.
280 N. Central Ave.
Hartsdale,  NY  10530
Applicant Contact VALERIO VAKRI
Correspondent
Infarkem Corp.
280 N. Central Ave.
Hartsdale,  NY  10530
Correspondent Contact VALERIO VAKRI
Regulation Number876.5820
Classification Product Code
FJK  
Date Received03/27/1985
Decision Date 07/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-