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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dna-probe kit, human chromosome
510(k) Number K972200
Device Name ANEUVYSION
Applicant
VYSIS
3100 WOODCREEK DR.
downers grove,  IL  60515
Applicant Contact russel k evans
Correspondent
VYSIS
3100 WOODCREEK DR.
downers grove,  IL  60515
Correspondent Contact russel k evans
Regulation Number866.4700
Classification Product Code
OYU  
Subsequent Product Code
KIR  
Date Received06/10/1997
Decision Date 10/20/1997
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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