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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 K862322
Device Name CHLAMYDIA KIT, STD KIT
Applicant
INTL. CYTOBRUSH, INC.
P.O. BOX 7733
HOLLYWOOD,  FL  33081
Applicant Contact TSE, PH.D.
Correspondent
INTL. CYTOBRUSH, INC.
P.O. BOX 7733
HOLLYWOOD,  FL  33081
Correspondent Contact TSE, PH.D.
Regulation Number884.4530
Classification Product Code
HHT  
Date Received06/19/1986
Decision Date 07/07/1986
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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