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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, Spinal Intervertebral Body
510(k) Number K041989
Device Name SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X
Applicant
Sintea Biotech, Inc.
407 Lincoln Rd.
Suite 10l
Miami Beach,  FL  33139
Applicant Contact ISABELLA ELIAS
Correspondent
Sintea Biotech, Inc.
407 Lincoln Rd.
Suite 10l
Miami Beach,  FL  33139
Correspondent Contact ISABELLA ELIAS
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received07/23/2004
Decision Date 09/16/2004
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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