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 Prosthesis, Tracheal, Expandable
510(k) Number K140472
Device Name BONASTENT TRACHEAL / BRONCHIAL
Applicant
ENDOCHOICE, INC.
1208-12 ROCKFORD RD.
TORONTO, ON,  CA M2R 3A2
Applicant Contact Bosmat Friedman
Correspondent
ENDOCHOICE, INC.
1208-12 ROCKFORD RD.
TORONTO, ON,  CA M2R 3A2
Correspondent Contact Bosmat Friedman
Regulation Number878.3720
Classification Product Code
JCT  
Date Received02/25/2014
Decision Date 10/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-