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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K891192
Device Name MEDI-TRACE THERMAL VIDEO FILM PAPER
Applicant
GRAPHIC CONTROLS CORP.
189 VAN RENSSELAER ST.
P.O. BOX 1274
BUFFALO,  NY  14240
Applicant Contact ALBERT J AMELOTTE
Correspondent
GRAPHIC CONTROLS CORP.
189 VAN RENSSELAER ST.
P.O. BOX 1274
BUFFALO,  NY  14240
Correspondent Contact ALBERT J AMELOTTE
Regulation Number892.2020
Classification Product Code
LMD  
Date Received03/06/1989
Decision Date 04/06/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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