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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 K063487
Device Name MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE
Applicant
Merete Medical GmbH
49 Purchase St.
Rye,  NY  10580
Applicant Contact DONNA COLEMAN
Correspondent
Merete Medical GmbH
49 Purchase St.
Rye,  NY  10580
Correspondent Contact DONNA COLEMAN
Regulation Number888.3030
Classification Product Code
KTT  
Date Received11/17/2006
Decision Date 01/22/2007
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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