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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scanner, Fluorescent
510(k) Number K911749
Device Name L-LINEX-RAY FLUORESCENCE
Applicant
Montifore Medical Center
111 E 210th St.
Bronx,  NY  10467
Applicant Contact JOHN F.ROSEN
Correspondent
Montifore Medical Center
111 E 210th St.
Bronx,  NY  10467
Correspondent Contact JOHN F.ROSEN
Regulation Number892.1220
Classification Product Code
JAO  
Date Received04/18/1991
Decision Date 08/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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