DISPOSABLE AMNIOTOME

Controller, Abortion Unit, Vacuum

GALENICA ENTERPRISES, INC.

The following data is part of a premarket notification filed by Galenica Enterprises, Inc. with the FDA for Disposable Amniotome.

Pre-market Notification Details

Device IDK883283
510k NumberK883283
Device Name:DISPOSABLE AMNIOTOME
ClassificationController, Abortion Unit, Vacuum
Applicant GALENICA ENTERPRISES, INC. C.P. 13 STE-THERESE Quebec Canada J7e 4h7,  CA
ContactJacques R Marcotte
CorrespondentJacques R Marcotte
GALENICA ENTERPRISES, INC. C.P. 13 STE-THERESE Quebec Canada J7e 4h7,  CA
Product CodeHGG  
CFR Regulation Number884.5070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-04
Decision Date1988-10-18

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