GRAFT, COOLEY GUIDELINE, STERILE

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Graft, Cooley Guideline, Sterile.

Pre-market Notification Details

Device IDK760090
510k NumberK760090
Device Name:GRAFT, COOLEY GUIDELINE, STERILE
ClassificationProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDSY  
CFR Regulation Number870.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-06-21
Decision Date1976-07-20

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