PROGENIX DBM PUTTY


Device Classification Name

bone grafting material, human source

510(k) Number K080462
Device Name PROGENIX DBM PUTTY
Applicant
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis, 
TN 
38132

Applicant Contact michelle obenauer
Correspondent
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis, 
TN 
38132

Correspodent Contact michelle obenauer
Regulation Number 872.3930
Classification Product Code
NUN  
Date Received 02/20/2008
Decision Date 05/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No