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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Root Canal
510(k) Number K112250
Device Name CHX=CHX PLUS
Applicant
INTER-MED, INC.
2200 NORTHWESTERN AVE.
RACINE,  WI  53404
Applicant Contact JOHN BAETEN
Correspondent
INTER-MED, INC.
2200 NORTHWESTERN AVE.
RACINE,  WI  53404
Correspondent Contact JOHN BAETEN
Classification Product Code
KJJ  
Date Received08/04/2011
Decision Date 10/28/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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