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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Dental Hand
510(k) Number K111465
Device Name COMPOTHIXO
Applicant
Kerrhawe SA
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact Wendy Garman
Correspondent
Kerrhawe SA
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact Wendy Garman
Regulation Number872.4565
Classification Product Code
DZN  
Date Received05/26/2011
Decision Date 07/25/2012
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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