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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cord, Retraction
510(k) Number K102133
Device Name GIRAFFE2
Applicant
Kerr Corporation
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact Wendy Garman
Correspondent
Kerr Corporation
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact Wendy Garman
Classification Product Code
MVL  
Date Received07/29/2010
Decision Date 10/07/2010
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
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