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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 K091613
Device Name TAKE 1
Applicant
Kerr Corp.
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact COLLEEN BOSWELL
Correspondent
Kerr Corp.
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.3660
Classification Product Code
ELW  
Date Received06/03/2009
Decision Date 10/07/2009
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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