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 Injector, Fluid, Non-Electrically Powered
510(k) Number K883847
Device Name DERATA MEDI-JECTOR V
Applicant
Derata Corp.
6701 Pkwy. Cir. Suite 100
Minneapolis,  MN  55430
Applicant Contact THOMAS J MALONEY
Correspondent
Derata Corp.
6701 Pkwy. Cir. Suite 100
Minneapolis,  MN  55430
Correspondent Contact THOMAS J MALONEY
Regulation Number880.5430
Classification Product Code
KZE  
Date Received09/12/1988
Decision Date 10/31/1988
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
-
-