ATRIUM C-QUR OVT MESH

Mesh, Surgical, Polymeric

ATRIUM MEDICAL CORP.

The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium C-qur Ovt Mesh.

Pre-market Notification Details

Device IDK100076
510k NumberK100076
Device Name:ATRIUM C-QUR OVT MESH
ClassificationMesh, Surgical, Polymeric
Applicant ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
ContactJacqueline Emery
CorrespondentJacqueline Emery
ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-12
Decision Date2010-01-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00650862316445 K100076 000
00650862316117 K100076 000
00650862316124 K100076 000
00650862316261 K100076 000
00650862316285 K100076 000
00650862316339 K100076 000
00650862316360 K100076 000
00650862316377 K100076 000
00650862316384 K100076 000
00650862316100 K100076 000

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