SET PP


Device Classification Name

cement, dental

510(k) Number K073043
Device Name SET PP
Applicant
SDI LTD.
5-9 brunsdon st.
bayswater, victoria, 

AU

3153

Applicant Contact ray cahill
Correspondent
SDI LTD.
5-9 brunsdon st.
bayswater, victoria, 

AU

3153

Correspodent Contact ray cahill
Regulation Number 872.3275
Classification Product Code
EMA  
Date Received 10/29/2007
Decision Date 12/14/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No