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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K120115
Device Name ORTHOSIZE
Applicant
ORTHOSIZE LLC
1835 MARKET STREET, 29TH FLOOR
PHILADELPHIA,  PA  19103
Applicant Contact YARMELA PAVLOVIC
Correspondent
ORTHOSIZE LLC
1835 MARKET STREET, 29TH FLOOR
PHILADELPHIA,  PA  19103
Correspondent Contact YARMELA PAVLOVIC
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/13/2012
Decision Date 03/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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