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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powder, porcelain
510(k) Number K042548
Device Name CERASYS - ZR
Applicant
CERASYS, INC.
11761 TELEGRAPH ROAD
SANTA FE SPRINGS,  CA  90670
Applicant Contact JIN KIM
Correspondent
CERASYS, INC.
11761 TELEGRAPH ROAD
SANTA FE SPRINGS,  CA  90670
Correspondent Contact JIN KIM
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/20/2004
Decision Date 12/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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