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 K894842
Device Name IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM
Applicant
IMED CORP.
9775 BUSINESSPARK AVE.
san diego,  CA  92131 -1699
Applicant Contact jarboe, phd
Correspondent
IMED CORP.
9775 BUSINESSPARK AVE.
san diego,  CA  92131 -1699
Correspondent Contact jarboe, phd
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/31/1989
Decision Date 09/12/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-