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 K921370
Device Name MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION
Applicant
MEDICAL INNOVATIONS CORP.
1595 MC-CANDLESS DR.
MILPITAS,  CA  95035
Applicant Contact DENNIS WONG
Correspondent
MEDICAL INNOVATIONS CORP.
1595 MC-CANDLESS DR.
MILPITAS,  CA  95035
Correspondent Contact DENNIS WONG
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/20/1992
Decision Date 05/02/1994
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-