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 K842174
Device Name PERCUTANEOUS GASTROSTOMY TUBE
Applicant
Mount Carmel Mercy Hospital
6071 W. Outer Dr.
Detroit,  MI  48235
Applicant Contact JASON H BODZIN
Correspondent
Mount Carmel Mercy Hospital
6071 W. Outer Dr.
Detroit,  MI  48235
Correspondent Contact JASON H BODZIN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/06/1984
Decision Date 12/07/1984
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
-
-