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 K810824
Device Name ERIKA HEPARIN INFUSION ADAPTOR
Applicant
Erika, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Erika, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5820
Classification Product Code
FJK  
Date Received03/24/1981
Decision Date 04/17/1981
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
-
-