AUTOSUTURE ABSORBABLE TACK AND APPLICATOR

Staple, Implantable

UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Autosuture Absorbable Tack And Applicator.

Pre-market Notification Details

Device IDK071920
510k NumberK071920
Device Name:AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
ClassificationStaple, Implantable
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
ContactDaniel Campion
CorrespondentDaniel Campion
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-12
Decision Date2007-09-28
Summary:summary

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