GEISTLICH COMBI-KIT COLLEGEN


Device Classification Name

bone grafting material, animal source

510(k) Number K112572
Device Name GEISTLICH COMBI-KIT COLLEGEN
Applicant
GEISTLICH PHARMA AG
555 twelfth street, nw
washington, 
DC 
20004 -1206

Applicant Contact daniel a kracov
Correspondent
GEISTLICH PHARMA AG
555 twelfth street, nw
washington, 
DC 
20004 -1206

Correspodent Contact daniel a kracov
Regulation Number 872.3930
Classification Product Code
NPM  
Date Received 09/06/2011
Decision Date 12/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No