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, Synthetic
510(k) Number K090850
Device Name ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
Applicant
Apatech , Ltd.
15058 Armel Dr.
Oregon City,  OR  97045
Applicant Contact CANDACE F CEDERMAN
Correspondent
Apatech , Ltd.
15058 Armel Dr.
Oregon City,  OR  97045
Correspondent Contact CANDACE F CEDERMAN
Regulation Number872.3930
Classification Product Code
LYC  
Date Received03/30/2009
Decision Date 07/30/2009
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
Recalls CDRH Recalls
-
-