INION CPS BABY 1.5 BIOABSORBABLE SYSTEM


Device Classification Name

plate, bone

510(k) Number K033194
Device Name INION CPS BABY 1.5 BIOABSORBABLE SYSTEM
Applicant
INION LTD.
laakarinkatu 2
tampere, 

FI

33520

Applicant Contact hanna marttila
Correspondent
INION LTD.
laakarinkatu 2
tampere, 

FI

33520

Correspodent Contact hanna marttila
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 10/02/2003
Decision Date 10/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No