CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P


Device Classification Name

filler, bone void, calcium compound

510(k) Number K022622
Device Name CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P
Original Applicant
BERKELEY ADVANCED BIOMATERIALS, INC.
1933 davis st. suite 307
san leandro, 
CA 
94577

Original Contact francois genin
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 08/07/2002
Decision Date 01/09/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No