CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ


Device Classification Name

filler, bone void, calcium compound

510(k) Number K030266
Device Name CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ
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 01/27/2003
Decision Date 02/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No