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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K082679
Device Name LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
Applicant
Sintea Biotech, Inc.
407 Lincoln Rd.
Suite 10l
Miami Beach,  FL  33139
Applicant Contact DANIELLE WERNIKOWSKI
Correspondent
Sintea Biotech, Inc.
407 Lincoln Rd.
Suite 10l
Miami Beach,  FL  33139
Correspondent Contact DANIELLE WERNIKOWSKI
Regulation Number888.3040
Classification Product Code
JEC  
Date Received09/15/2008
Decision Date 04/07/2009
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
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