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 and syringe, angiographic
510(k) Number K071691
Device Name DUAL SHOT ALPHA
Applicant
NEMOTO KYORINDO CO., LTD.
24992 DEL MONTE ST.
LAGUNA HILLS,  CA  92653 -5617
Applicant Contact MICHAEL HIEDA
Correspondent
NEMOTO KYORINDO CO., LTD.
24992 DEL MONTE ST.
LAGUNA HILLS,  CA  92653 -5617
Correspondent Contact MICHAEL HIEDA
Regulation Number870.1650
Classification Product Code
DXT  
Date Received06/20/2007
Decision Date 12/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
-
-