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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 K870782
Device Name CYCLO-BRUSH
Applicant
Medline Industries, Inc.
99 Inverness Dr. E.
Englewood,  CO  80112
Applicant Contact JO BREHM
Correspondent
Medline Industries, Inc.
99 Inverness Dr. E.
Englewood,  CO  80112
Correspondent Contact JO BREHM
Regulation Number884.4530
Classification Product Code
HHT  
Date Received02/26/1987
Decision Date 05/18/1987
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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