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 Tube, Gastro-Enterostomy
510(k) Number K910584
Device Name ONE STEP BUTTON(TM)
Applicant
APPLIED MEDICAL TECHNOLOGIES
6100 WEST CREEK RD.
SUITE 25
INDEPENDENCE,  OH  44131
Applicant Contact PAT GILPIN
Correspondent
APPLIED MEDICAL TECHNOLOGIES
6100 WEST CREEK RD.
SUITE 25
INDEPENDENCE,  OH  44131
Correspondent Contact PAT GILPIN
Regulation Number876.5980
Classification Product Code
KGC  
Date Received02/11/1991
Decision Date 05/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-