ATRIUM MEDICAL CORPORATION C-QUR 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 Medical Corporation C-qur Mesh.

Pre-market Notification Details

Device IDK050311
510k NumberK050311
Device Name:ATRIUM MEDICAL CORPORATION C-QUR MESH
ClassificationMesh, Surgical, Polymeric
Applicant ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
ContactJoseph P De Paolo
CorrespondentJoseph P De Paolo
ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-08
Decision Date2006-03-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00650862315912 K050311 000
00650862315066 K050311 000
00650862315073 K050311 000
00650862315264 K050311 000
00650862315271 K050311 000
00650862315288 K050311 000
00650862315318 K050311 000
00650862315332 K050311 000
00650862315349 K050311 000
00650862315356 K050311 000
00650862315363 K050311 000
00650862315370 K050311 000
00650862315387 K050311 000
00650862315400 K050311 000
00650862315424 K050311 000
00650862315431 K050311 000
00650862315448 K050311 000
00650862315059 K050311 000

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