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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, bone
510(k) Number K102641
Device Name MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE
Applicant
NEOORTHO PRODUTOS ORTOPEDICOS S/A
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Applicant Contact LINDA K SCHULZ
Correspondent
NEOORTHO PRODUTOS ORTOPEDICOS S/A
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Correspondent Contact LINDA K SCHULZ
Regulation Number872.4760
Classification Product Code
JEY  
Date Received09/13/2010
Decision Date 12/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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