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 K926119
Device Name EXEL HUBER INFUSION SET ROTATING WING
Applicant
Exel Intl.
P.O. Box 3194
Culver City,  CA  90231
Applicant Contact HAMID
Correspondent
Exel Intl.
P.O. Box 3194
Culver City,  CA  90231
Correspondent Contact HAMID
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/03/1992
Decision Date 08/11/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-