UNI-GRAFT K DV VASCULAR GRAFT

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

ATRIUM MEDICAL CORP.

The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Uni-graft K Dv Vascular Graft.

Pre-market Notification Details

Device IDK991813
510k NumberK991813
Device Name:UNI-GRAFT K DV VASCULAR GRAFT
ClassificationProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
ContactJoe De Paolo
CorrespondentJoe De Paolo
ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
Product CodeDSY  
CFR Regulation Number870.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-27
Decision Date1999-06-01
Summary:summary

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