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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K070016
Device Name BLUE SHARK
Applicant
Meridan Medical
3722 Ave., Sausalito
Irvine,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
Meridan Medical
3722 Ave., Sausalito
Irvine,  CA  92606
Correspondent Contact GRACE HOLLAND
Regulation Number888.3030
Classification Product Code
KTT  
Date Received01/03/2007
Decision Date 04/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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