CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA

Spatula, Cervical, Cytological

TRIDAK DIVISION OF INDICON, INC.

The following data is part of a premarket notification filed by Tridak Division Of Indicon, Inc. with the FDA for Cytological Cervical Spatula The Multi-spatula.

Pre-market Notification Details

Device IDK851934
510k NumberK851934
Device Name:CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA
ClassificationSpatula, Cervical, Cytological
Applicant TRIDAK DIVISION OF INDICON, INC. ONE BLUE HILL PLAZA SUITE 815 Pearl River,  NY  10965
ContactCorinne M Ambrosino
CorrespondentCorinne M Ambrosino
TRIDAK DIVISION OF INDICON, INC. ONE BLUE HILL PLAZA SUITE 815 Pearl River,  NY  10965
Product CodeHHT  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-06
Decision Date1985-07-05

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