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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K933372
Device Name VISIONLINK INTERFILE CONVERSION SOFTWARE
Applicant
Evergreen Technologies, Inc.
Main St.
P.O. Box 795
Castine,  ME  04421
Applicant Contact KAREN SIEGEL
Correspondent
Evergreen Technologies, Inc.
Main St.
P.O. Box 795
Castine,  ME  04421
Correspondent Contact KAREN SIEGEL
Regulation Number892.1200
Classification Product Code
KPS  
Date Received07/09/1993
Decision Date 11/01/1993
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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