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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brush, Endometrial
510(k) Number K897070
Device Name ENDOBRUSH(TM) DEVICE; OMNIBRUSH
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 Number884.1100
Classification Product Code
HFE  
Date Received12/22/1989
Decision Date 09/10/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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