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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 K875162
Device Name ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH
Applicant
ORTHO DIAGNOSTIC SYSTEMS, INC.
1125 MARK AVE.
CARPINTERIA,  CA  93013
Applicant Contact LARRY D MCCLAIN,PHD
Correspondent
ORTHO DIAGNOSTIC SYSTEMS, INC.
1125 MARK AVE.
CARPINTERIA,  CA  93013
Correspondent Contact LARRY D MCCLAIN,PHD
Regulation Number884.4530
Classification Product Code
HHT  
Date Received12/16/1987
Decision Date 01/27/1988
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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