AMIELLE

Stent, Vaginal

Owen Mumford USA, Inc.

The following data is part of a premarket notification filed by Owen Mumford Usa, Inc. with the FDA for Amielle.

Pre-market Notification Details

Device IDK983045
510k NumberK983045
Device Name:AMIELLE
ClassificationStent, Vaginal
Applicant Owen Mumford USA, Inc. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta,  GA  30062
ContactRobert E Shaw
CorrespondentRobert E Shaw
Owen Mumford USA, Inc. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta,  GA  30062
Product CodeKXP  
CFR Regulation Number884.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-01
Decision Date1998-11-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00384702190017 K983045 000
00384702101013 K983045 000
00384702102010 K983045 000
00384702103017 K983045 000
00384702104014 K983045 000
00384702105011 K983045 000
00384702171016 K983045 000
00384702172013 K983045 000
00384702173010 K983045 000
00384702174017 K983045 000
00384702178015 K983045 000
00384702179012 K983045 000
00384702100030 K983045 000

Trademark Results [AMIELLE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AMIELLE
AMIELLE
86102398 5061716 Live/Registered
Owen Mumford Limited
2013-10-25

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