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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 K110871
Device Name FIT CHECKER ADVANCED
Applicant
GC America, Inc.
3737 W 127th St.
Alsip,  IL  60803
Applicant Contact MARK HEISS
Correspondent
GC America, Inc.
3737 W 127th St.
Alsip,  IL  60803
Correspondent Contact MARK HEISS
Regulation Number872.3660
Classification Product Code
ELW  
Date Received03/29/2011
Decision Date 06/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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