FDA 510(k) Applications for Medical Device:
Orthosis, Cranial, Laser Scan

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K081787 BIOSCULPTOR CORPORATION 2480 WEST 82ND STREET #8
HIALEAH FL 33016
K072862 BOSTON BRACE INTL., INC. 20 LEDIN DR.
AVON MA 02322
K063098 BOSTON BRACE INTL., INC. 20 LEDIN DR.
AVON MA 02322
K014012 CRANIAL TECHNOLOGIES, INC. 1395 WEST AUTO DR.
TEMPE AZ 85284
K072566 HANGER PROSTHETICS & ORTHOTICS, INC. 700 12TH STREET, NW
WASHINGTON DC 20005
K211376 Orthomerica Products Inc. 6333 North Orange Blossom Trail
Orlando FL 32810
K203098 Orthomerica Products Inc. 6333 North Orange Blossom Trail
Orlando FL 32810
K180109 Orthomerica Products, Inc 6333 North Orange Blossom Trail
Orlando FL 32810
K021918 ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM
ORLANDO FL 32810
K161138 ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM TRAIL
ORLANDO FL 32810
K124023 ORTHOMERICA PRODUCTS, INC. 6333 N Orange Blossom Trl
ORLANDO FL 32810
K082950 ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM
ORLANDO FL 32810
K011350 ORTHOMERICA PRODUCTS, INC. 1001 PENNSYLVANIA AVE.
WASHINGTON DC 20004
K142141 ORTHOMERICA PRODUCTS, INC. 6333 North Orange Blossom Trail
Orlando FL 32810
K151147 ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM TRAIL
ORLANDO FL 32810
K151979 ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM TRAIL
ORLANDO FL 32810
K081994 ORTHOMERICA PRODUCTS, INC. 6333 N. ORANGE BLOSSOM TRAIL
ORLANDO FL 32810
K090587 ORTHOMERICA PRODUCTS, INC. 6333 N. ORANGE BLOSSOM TRAIL
ORLANDO FL 32810
K021207 ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM
ORLANDO FL 32810
K082945 ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM
ORLANDO FL 32810
K133250 ORTHOMERICA PRODUCTS, INC. 6333 North Orange Blossom Trail
Orlando FL 32810




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