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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K070854
Device Name GC MI PASTE PLUS
Applicant
GC America, Inc.
3737 W. 127th St.
Alsip,  IL  60803
Applicant Contact TERRY L JORITZ-LYONS
Correspondent
GC America, Inc.
3737 W. 127th St.
Alsip,  IL  60803
Correspondent Contact TERRY L JORITZ-LYONS
Regulation Number872.6030
Classification Product Code
EJR  
Date Received03/28/2007
Decision Date 04/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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