COMPOTHIXO


Device Classification Name

instruments, dental hand

510(k) Number K111465
Device Name COMPOTHIXO
Applicant
KERRHAWE SA
1717 west collins avenue
orange, 
CA 
92867

Applicant Contact wendy garman
Correspondent
KERRHAWE SA
1717 west collins avenue
orange, 
CA 
92867

Correspodent Contact wendy garman
Regulation Number 872.4565
Classification Product Code
DZN  
Date Received 05/26/2011
Decision Date 07/25/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No