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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
Predetermined Change
Control Plan Authorized		 No
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