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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
Device Name INFRASCANNER
Applicant
INFRASCAN, INC.
1835 MARKET ST., 29TH FLOOR
PHILADELPHIA,  PA  19103
Applicant Contact STEVEN B DATLOF, M.D., J.D.
Correspondent
INFRASCAN, INC.
1835 MARKET ST., 29TH FLOOR
PHILADELPHIA,  PA  19103
Correspondent Contact STEVEN B DATLOF, M.D., J.D.
Regulation Number882.1935
Classification Product Code
OPT  
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
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