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 K121270
Device Name BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
Applicant
BIOJECT MEDICAL TECHNOLOGIES INC.
7180 SW Sandburg St Ste 100
Tigard,  OR  97223
Applicant Contact CHRISTINE BREITBACH
Correspondent
BIOJECT MEDICAL TECHNOLOGIES INC.
7180 SW Sandburg St Ste 100
Tigard,  OR  97223
Correspondent Contact CHRISTINE BREITBACH
Regulation Number880.5430
Classification Product Code
KZE  
Date Received04/26/2012
Decision Date 07/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-