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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K052248
Device Name DORSAL NAIL PLATE, ANATOMICAL
Applicant
Hand Innovations, LLC
8905 SW 87th Ave.,
Suite 220
Miami Lakes,  FL  33176
Applicant Contact ERNESTO HERNANDEZ
Correspondent
Hand Innovations, LLC
8905 SW 87th Ave.,
Suite 220
Miami Lakes,  FL  33176
Correspondent Contact ERNESTO HERNANDEZ
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/18/2005
Decision Date 09/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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