GENEX PUTTY


Device Classification Name

filler, bone void, calcium compound

510(k) Number K073341
Device Name GENEX PUTTY
Applicant
BIOCOMPOSITES LTD.
keele science park
keele, staffordshire, 

GB

st5 5nl

Applicant Contact simon fitzer
Correspondent
BIOCOMPOSITES LTD.
keele science park
keele, staffordshire, 

GB

st5 5nl

Correspodent Contact simon fitzer
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 11/28/2007
Decision Date 07/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No