ATRIUM PROLITE ULTRA S 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 Prolite Ultra S Mesh.

Pre-market Notification Details

Device IDK070192
510k NumberK070192
Device Name:ATRIUM PROLITE ULTRA S 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-22
Decision Date2007-03-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.