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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, abortion, vacuum
510(k) Number K904160
Device Name CYTOSMEAR BRUSH
Applicant
BROOKE INTL.
3555 LANDFAIR RD.
PASADENA,  CA  91107
Applicant Contact TODD M GATES
Correspondent
BROOKE INTL.
3555 LANDFAIR RD.
PASADENA,  CA  91107
Correspondent Contact TODD M GATES
Regulation Number884.5070
Classification Product Code
HHI  
Date Received09/11/1990
Decision Date 11/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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