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 Trocar
510(k) Number K914985
Device Name DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
Applicant
E-Z-EM, INC.
P.O. BOX 993
266 QUEENSBURY AVENUE
GLENS FALLS,  NY  12801
Applicant Contact MERRIBETH ADAMS
Correspondent
E-Z-EM, INC.
P.O. BOX 993
266 QUEENSBURY AVENUE
GLENS FALLS,  NY  12801
Correspondent Contact MERRIBETH ADAMS
Regulation Number870.1390
Classification Product Code
DRC  
Date Received10/23/1991
Decision Date 12/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-