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 pump, infusion
510(k) Number K100798
Device Name MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
Applicant
MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA,  PA  15051
Applicant Contact SUSAN LYNN FELIX
Correspondent
MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA,  PA  15051
Correspondent Contact SUSAN LYNN FELIX
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/22/2010
Decision Date 06/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-