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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 K874604
Device Name HISTOBRUSH
Applicant
Spectrum Co.
60916 Terminal Annex
Los Angeles,  CA  90060
Applicant Contact TIMOTHY J WEBBER
Correspondent
Spectrum Co.
60916 Terminal Annex
Los Angeles,  CA  90060
Correspondent Contact TIMOTHY J WEBBER
Regulation Number884.4530
Classification Product Code
HHT  
Date Received11/09/1987
Decision Date 01/07/1988
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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