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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name infrared hematoma detector
510(k) Number K120949
Original Applicant
1835 market st., 29th floor
philadelphia,  PA  19103
Original Contact steven b datlof, m.d., j.d.
Regulation Number882.1935
Classification Product Code
Date Received03/30/2012
Decision Date 01/11/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No