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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K151762
Device Name PediatrOS RigidTack/FlexTack
Applicant
Merete Medical GmbH
Alt-Lankwitz 102
Berlin,  DE 12247
Applicant Contact EMMANUEL ANAPLIOTIS
Correspondent
Merete Medical, Inc.
4 Crotty Lane, Suite 118
New York International Plaza
New Windsor,  NY  12553
Correspondent Contact Matthias Möllmann
Regulation Number888.3030
Classification Product Code
JDR  
Subsequent Product Code
OBT  
Date Received06/29/2015
Decision Date 12/28/2015
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
Recalls CDRH Recalls
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