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 Stopcock, I.V. Set
510(k) Number K190489
Device Name Elcam Stopcocks and Manifolds
Applicant
Elcam Medical Acal
Kibbutz Baram
-,  IL 1386000
Applicant Contact Avital Levertov
Correspondent
Elcam Medical Acal
Kibbutz Baram
-,  IL 1386000
Correspondent Contact Avital Levertov
Regulation Number880.5440
Classification Product Code
FMG  
Date Received02/28/2019
Decision Date 04/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-