MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE

Extractor, Vacuum, Fetal

NEWARD ENTERPRISES, INC.

The following data is part of a premarket notification filed by Neward Enterprises, Inc. with the FDA for Mityvac Super M Style Vacum Extractor, Disposable.

Pre-market Notification Details

Device IDK943938
510k NumberK943938
Device Name:MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE
ClassificationExtractor, Vacuum, Fetal
Applicant NEWARD ENTERPRISES, INC. 9251 ARCHIBALD AVE. P.O. BOX 725 Rancho Cucamonga,  CA  91729 -0725
ContactAllyson C Carmark
CorrespondentAllyson C Carmark
NEWARD ENTERPRISES, INC. 9251 ARCHIBALD AVE. P.O. BOX 725 Rancho Cucamonga,  CA  91729 -0725
Product CodeHDB  
CFR Regulation Number884.4340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-12
Decision Date1995-05-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30888937003056 K943938 000

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