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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 K100695
Device Name COLLADENTAL BARRIER
Applicant
COLLAMATRIX, INC
26f, no. 105, section 2 dunhua
south road, da-an distric
taipei, 
Contact dennis j. n. seah
Regulation Number872.3930
Classification Product Code
NPL  
Date Received03/15/2010
Decision Date 01/03/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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