OSTEOGRAF/N-300 HYDROXYLAPATITE


Device Classification Name

bone grafting material, synthetic

510(k) Number K960348
Device Name OSTEOGRAF/N-300 HYDROXYLAPATITE
Applicant
CERAMED CORP.
12860 west cedar dr., ste. 110
lakewood, 
CO 
80228

Applicant Contact barbara a watson
Correspondent
CERAMED CORP.
12860 west cedar dr., ste. 110
lakewood, 
CO 
80228

Correspodent Contact barbara a watson
Regulation Number 872.3930
Classification Product Code
LYC  
Date Received 01/25/1996
Decision Date 04/22/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized