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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Spatula, Cervical, Cytological
510(k) Number K861389
Device Name PAP SMEAR KIT
Applicant
INTL. CYTOBRUSH, INC.
P.O. BOX 7733
HOLLYWOOD,  FL  33081
Applicant Contact TENNY P TSE
Correspondent
INTL. CYTOBRUSH, INC.
P.O. BOX 7733
HOLLYWOOD,  FL  33081
Correspondent Contact TENNY P TSE
Regulation Number884.4530
Classification Product Code
HHT  
Date Received04/14/1986
Decision Date 05/02/1986
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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