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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
510(k) Number K072251
Device Name MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
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
Classification Product Code
LZJ  
Date Received08/13/2007
Decision Date 05/08/2008
Decision Substantially Equivalent (SESE)
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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