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 Tubes, Gastrointestinal (And Accessories)
510(k) Number K083684
Device Name ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX
Applicant
Manufacturing & Research, Inc.
4700 S. Overland Dr.
Tucson,  AZ  85745
Applicant Contact SUZANNE DEW
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/12/2008
Decision Date 02/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-