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 pump, air, non-manual, for endoscope
510(k) Number K120862
Device Name WATER BOTTLE CAP IRRIGATON SYSTEM
Applicant
ENDOCHOICE, INC.
11810 WILLS ROAD
SUITE 100
ALPHARETTA,  GA  30009
Applicant Contact THERON GOBER
Correspondent
ENDOCHOICE, INC.
11810 WILLS ROAD
SUITE 100
ALPHARETTA,  GA  30009
Correspondent Contact THERON GOBER
Regulation Number876.1500
Classification Product Code
FEQ  
Date Received03/22/2012
Decision Date 11/27/2012
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
-
-