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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 K040567
Device Name GC INITIAL MC, AL AND LF
Applicant
GC AMERICA, INC.
3737 WEST 127TH ST.
ALSIP,  IL  60803
Applicant Contact TERRY L JORITZ
Correspondent
GC AMERICA, INC.
3737 WEST 127TH ST.
ALSIP,  IL  60803
Correspondent Contact TERRY L JORITZ
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/04/2004
Decision Date 04/22/2004
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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