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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 K082470
Device Name SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
Applicant
Inter-Med, Inc.
2200 Northwestern Ave.
Racine,  WI  53404
Applicant Contact GEORGE HORVAT
Correspondent
Inter-Med, Inc.
2200 Northwestern Ave.
Racine,  WI  53404
Correspondent Contact GEORGE HORVAT
Classification Product Code
KJJ  
Date Received08/27/2008
Decision Date 04/03/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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