EQUIMATRIX


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

Correspodent Contact marsha simon
Regulation Number 872.3930
Classification Product Code
NPM  
Date Received 06/27/2011
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