• 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 K111816
Device Name EQUIMATRIX
Applicant
LUITPOLD PHARMACEUTICALS, INC.
ONE LUITPOLD DR.
P.O. BOX 9001
SHIRLEY,  NY  11967
Applicant Contact MARSHA SIMON
Correspondent
LUITPOLD PHARMACEUTICALS, INC.
ONE LUITPOLD DR.
P.O. BOX 9001
SHIRLEY,  NY  11967
Correspondent Contact MARSHA SIMON
Regulation Number872.3930
Classification Product Code
NPM  
Date Received06/27/2011
Decision Date 09/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-