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FDA 510(k) Application Details - K153128
Device Classification Name
Spatula, Cervical, Cytological
More FDA Info for this Device
510(K) Number
K153128
Device Name
Spatula, Cervical, Cytological
Applicant
KOLPLAST CI SA
ESTRADA MUNICIPAL IVA 136. NO 418. BARRIO DA MINA
ITUPEVA- SP 13295-000 BR
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Contact
DANIELA FERACIN
Other 510(k) Applications for this Contact
Regulation Number
884.4530
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Classification Product Code
HHT
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More FDA Info for this Product Code
Date Received
10/29/2015
Decision Date
01/13/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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