AXYAFLEX POLYESTER SUTURE

Suture, Nonabsorbable, Synthetic, Polyethylene

AXYA MEDICAL, INC.

The following data is part of a premarket notification filed by Axya Medical, Inc. with the FDA for Axyaflex Polyester Suture.

Pre-market Notification Details

Device IDK060165
510k NumberK060165
Device Name:AXYAFLEX POLYESTER SUTURE
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly,  MA  01915
ContactHoward Schrayer
CorrespondentHoward Schrayer
AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly,  MA  01915
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-23
Decision Date2006-09-01
Summary:summary

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