WALLACH CC/BRUSH

Spatula, Cervical, Cytological

WALLACH SURGICAL DEVICES, INC.

The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Cc/brush.

Pre-market Notification Details

Device IDK896065
510k NumberK896065
Device Name:WALLACH CC/BRUSH
ClassificationSpatula, Cervical, Cytological
Applicant WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford,  CT  06460
ContactVincent Frazzetta
CorrespondentVincent Frazzetta
WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford,  CT  06460
Product CodeHHT  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-18
Decision Date1990-01-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30888937013291 K896065 000
20888937011320 K896065 000
20888937011313 K896065 000
20888937011306 K896065 000
20888937011290 K896065 000
50888937011284 K896065 000
50888937011277 K896065 000

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