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 Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K002778
Device Name ENTERIC INJECTION CATHETER WITH IRRIGATION
Applicant
Enteric Medical Technologies, Inc.
1125 E. Hillsdale Blvd.
Suite 106
Foster City,  CA  94404
Applicant Contact JILL M VISOR
Correspondent
Enteric Medical Technologies, Inc.
1125 E. Hillsdale Blvd.
Suite 106
Foster City,  CA  94404
Correspondent Contact JILL M VISOR
Regulation Number876.1500
Classification Product Code
FBK  
Date Received09/06/2000
Decision Date 11/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-