APAPORE BONE GRAFT SUBSTITUTE

Device Classification Name

filler, bone void, calcium compound

510(k) Number K033722
Device Name APAPORE BONE GRAFT SUBSTITUTE
Applicant
APATECH LTD.
195 west st.
waltham, 
MA 
02451

Applicant Contact barry sall
Correspondent
APATECH LTD.
195 west st.
waltham, 
MA 
02451

Correspodent Contact barry sall
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 11/26/2003
Decision Date 05/07/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No