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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 K153128
Device Name Kolplast Cervical Sample Collection Kit
Applicant
Kolplast CI SA
Estrada Municipal Iva 136. No 418. Barrio Da Mina
Itupeva- Sp,  BR 13295-000
Applicant Contact DANIELA FERACIN
Correspondent
Smith Assoicates
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact YOLANDA SMITH
Regulation Number884.4530
Classification Product Code
HHT  
Date Received10/29/2015
Decision Date 01/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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