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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name barrier, animal source, intraoral
510(k) Number K053260
Device Name OSSIX -PLUS
Applicant
COLBAR LIFESCIENCE LTD.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
COLBAR LIFESCIENCE LTD.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number872.3930
Classification Product Code
NPL  
Date Received11/22/2005
Decision Date 02/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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