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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Synthetic, Intraoral
510(k) Number K033074
Device Name INION GTR BIODEGRADABLE MEMBRANE 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 Number872.3930
Classification Product Code
NPK  
Date Received09/29/2003
Decision Date 03/31/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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