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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name material, impression
510(k) Number K121824
Device Name ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2
Original Applicant
LASCOD SPA
2600 mullininix mill road
mt. airy,  MD  21771
Original Contact blix winston
Regulation Number872.3660
Classification Product Code
ELW  
Date Received06/21/2012
Decision Date 08/23/2012
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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