SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)

Suture, Nonabsorbable, Synthetic, Polypropylene

AXYA MEDICAL, INC.

The following data is part of a premarket notification filed by Axya Medical, Inc. with the FDA for Suture Welding System And Kit-(j-tip Design).

Pre-market Notification Details

Device IDK002557
510k NumberK002557
Device Name:SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)
ClassificationSuture, Nonabsorbable, Synthetic, Polypropylene
Applicant AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly,  MA  01915
ContactHoward L Schrayer
CorrespondentHoward L Schrayer
AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly,  MA  01915
Product CodeGAW  
CFR Regulation Number878.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-17
Decision Date2000-10-06

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