MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT

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(r) Saftisoft Obstetrical Vacuum Deliv Kit.

Pre-market Notification Details

Device IDK913324
510k NumberK913324
Device Name:MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT
ClassificationExtractor, Vacuum, Fetal
Applicant NEWARD ENTERPRISES, INC. P.O. BOX 725 9251 ARCHIBALD AVENUE Cucamonga,  CA  91730
ContactJohn T Murray
CorrespondentJohn T Murray
NEWARD ENTERPRISES, INC. P.O. BOX 725 9251 ARCHIBALD AVENUE Cucamonga,  CA  91730
Product CodeHDB  
CFR Regulation Number884.4340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-25
Decision Date1992-06-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30888937003070 K913324 000

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