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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact HANNA MARTTILA
Regulation Number872.4760
Classification Product Code
JEY  
Date Received10/02/2003
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
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