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 K133189
Device Name DUAL SHOT ALPHA 7
Applicant
Nemoto Kyorindo Co., Ltd.
2-27-20 Hongo
Bunkyo-Ku,  JP 113-0033
Applicant Contact KEN WAKABAYASHI
Correspondent
Nemoto Kyorindo Co., Ltd.
2-27-20 Hongo
Bunkyo-Ku,  JP 113-0033
Correspondent Contact KEN WAKABAYASHI
Regulation Number870.1650
Classification Product Code
DXT  
Date Received10/17/2013
Decision Date 06/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-