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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liner, Cavity, Calcium Hydroxide
510(k) Number K001050
Device Name CALCIJECT
Applicant
CENTRIX, INC.
770 RIVER RD.
SHELTON,  CT  06484 -5458
Applicant Contact SCOTT COHN
Correspondent
CENTRIX, INC.
770 RIVER RD.
SHELTON,  CT  06484 -5458
Correspondent Contact SCOTT COHN
Regulation Number872.3250
Classification Product Code
EJK  
Date Received03/31/2000
Decision Date 07/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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