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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 K911432
Device Name ACCELLON CERVICAL BIOSAMPLER
Applicant
Medscand AB
P.O. Box 20047
Malmo,  SE 520074
Applicant Contact TENNY P TSE
Correspondent
Medscand AB
P.O. Box 20047
Malmo,  SE 520074
Correspondent Contact TENNY P TSE
Regulation Number884.4530
Classification Product Code
HHT  
Date Received04/02/1991
Decision Date 09/03/1993
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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