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, administration, intravascular
510(k) Number K231707
Device Name ResQ Administration Set
Applicant
Q for Plastic Industries
Land plot #25,27.first industrial zone
Badr,  EG 11829
Applicant Contact Islam Nazieh Mohamed Ali
Correspondent
Global Quality and Regulatory Services
10 Scenic Way
Monroe,  NJ  08831
Correspondent Contact Abdel B Halim
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/12/2023
Decision Date 01/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-