• 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 bulb, inflation, for endoscope
510(k) Number K093718
Device Name ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003
Applicant
ZUTRON MEDICAL LLC
9816 PFLUMM RD
LENEXA,  KS  66215
Applicant Contact JORDAN HARTONG
Correspondent
ZUTRON MEDICAL LLC
9816 PFLUMM RD
LENEXA,  KS  66215
Correspondent Contact JORDAN HARTONG
Regulation Number876.1500
Classification Product Code
FCY  
Date Received12/02/2009
Decision Date 02/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-