• 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 pump, infusion or syringe, extra-luminal
510(k) Number K932055
Device Name PERCUPUMP II
Applicant
E-Z-EM, INC.
717 MAIN ST.
WESTBURY,  NY  11590
Applicant Contact MERRIBETH ADAMS
Correspondent
E-Z-EM, INC.
717 MAIN ST.
WESTBURY,  NY  11590
Correspondent Contact MERRIBETH ADAMS
Regulation Number876.5820
Classification Product Code
FIH  
Date Received04/28/1993
Decision Date 03/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-