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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K952493
Device Name FLUORECORD MODEL 762
Applicant
Syracuse Scientific, Inc.
75836 Murray Dr.
Cicero,  NY  13039
Applicant Contact JACK RACE
Correspondent
Syracuse Scientific, Inc.
75836 Murray Dr.
Cicero,  NY  13039
Correspondent Contact JACK RACE
Regulation Number892.1650
Classification Product Code
JAA  
Date Received05/30/1995
Decision Date 06/22/1995
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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