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 stents, drains and dilators for the biliary ducts
510(k) Number K861291
Device Name GASTROTOPO
Applicant
HOUSTON BIOMEDICAL, INC.
1900 YORKTOWN STE 400
HOUSTON,  TX  77056
Applicant Contact DAVID P SUMMERS
Correspondent
HOUSTON BIOMEDICAL, INC.
1900 YORKTOWN STE 400
HOUSTON,  TX  77056
Correspondent Contact DAVID P SUMMERS
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/07/1986
Decision Date 05/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-