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 K110449
Device Name ENDOBON XENOGRAFT GRANULES
Applicant
BIOMET 3I
4555 RIVERSIDE DRIVE
PALM BEACH GARDENS,  FL  33410
Applicant Contact MARTHA I GARAY
Correspondent
BIOMET 3I
4555 RIVERSIDE DRIVE
PALM BEACH GARDENS,  FL  33410
Correspondent Contact MARTHA I GARAY
Regulation Number872.3930
Classification Product Code
LYC  
Date Received02/16/2011
Decision Date 05/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-