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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Light, Microscope
510(k) Number K874750
Device Name VIDEO ANALYZER 4000
Applicant
SCIENTIFIC IMAGING, INC.
21 CASTLE AVE.
FAIRFIELD,  CT  06830
Applicant Contact STEVEN R GRIFFIN
Correspondent
SCIENTIFIC IMAGING, INC.
21 CASTLE AVE.
FAIRFIELD,  CT  06830
Correspondent Contact STEVEN R GRIFFIN
Regulation Number864.3600
Classification Product Code
IBJ  
Date Received11/18/1987
Decision Date 04/25/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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