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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 K102688
Device Name MERETE LOCKING BONE PLATE SYSTEM II
Applicant
Merete Medical GmbH
49 Purchase St.
Rye,  NY  10580
Applicant Contact EMMANUEL ANAPLIOTIS
Correspondent
Merete Medical GmbH
49 Purchase St.
Rye,  NY  10580
Correspondent Contact EMMANUEL ANAPLIOTIS
Regulation Number888.3030
Classification Product Code
KTT  
Date Received09/17/2010
Decision Date 12/03/2010
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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