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 K872771
Device Name LOW PROFILE GASTROSTOMY
Applicant
MICROVASIVE
31 MAPLE ST.
MILFORD,  MA  01757
Applicant Contact SAMUEL D WADE
Correspondent
MICROVASIVE
31 MAPLE ST.
MILFORD,  MA  01757
Correspondent Contact SAMUEL D WADE
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/14/1987
Decision Date 10/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-