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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K023888
Device Name CIMOFLUOR
Applicant
Global Dental Products, Inc.
P.O. Box 537
North Bellmore,  NY  11710
Applicant Contact JERRY L BARTICK
Correspondent
Global Dental Products, Inc.
P.O. Box 537
North Bellmore,  NY  11710
Correspondent Contact JERRY L BARTICK
Regulation Number872.3275
Classification Product Code
EMA  
Subsequent Product Code
KIF  
Date Received11/21/2002
Decision Date 03/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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