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 Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
510(k) Number K240433
Device Name ProSeal™ Injection Site Extended Male Luer Lock (422140)
Applicant
Epic Medical Pte. , Ltd.
105 Cecil St. #20-04, The Octagon, Singapore 069534
Singapore,  SG 069534
Applicant Contact Freddie Lee
Correspondent
Epic Medical Pte. , Ltd.
105 Cecil St. #20-04, The Octagon, Singapore 069534
Singapore,  SG 069534
Correspondent Contact Freddie Lee
Regulation Number880.5440
Classification Product Code
ONB  
Date Received02/14/2024
Decision Date 05/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-