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 Bone Grafting Material, Animal Source
510(k) Number K140021
Device Name TI-OSS
Applicant
Chiyewon
4568 W. 1st St. Suite 104
Los Angeles,  CA  90004
Applicant Contact DANIEL NAM
Correspondent
Chiyewon
4568 W. 1st St. Suite 104
Los Angeles,  CA  90004
Correspondent Contact DANIEL NAM
Regulation Number872.3930
Classification Product Code
NPM  
Date Received01/03/2014
Decision Date 06/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-