INNOVASIVE DEVICES Y-KNOT SUTURE CLIP

Endoscopic Tissue Approximation Device

INNOVASIVE DEVICES, INC.

The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Innovasive Devices Y-knot Suture Clip.

Pre-market Notification Details

Device IDK973313
510k NumberK973313
Device Name:INNOVASIVE DEVICES Y-KNOT SUTURE CLIP
ClassificationEndoscopic Tissue Approximation Device
Applicant INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough,  MA  01752
ContactEric Bannon
CorrespondentEric Bannon
INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough,  MA  01752
Product CodeOCW  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-03
Decision Date1997-12-01
Summary:summary

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