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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
Applicant
LASCOD SPA
2600 MULLININIX MILL ROAD
MT. AIRY,  MD  21771
Applicant Contact BLIX WINSTON
Correspondent
LASCOD SPA
2600 MULLININIX MILL ROAD
MT. AIRY,  MD  21771
Correspondent 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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