AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR

Retractor

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 Auto Suture(r) Endoscopic Fan Retractor.

Pre-market Notification Details

Device IDK914190
510k NumberK914190
Device Name:AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
ClassificationRetractor
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
ContactSteve Reitzler
CorrespondentSteve Reitzler
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
Product CodeGAD  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-18
Decision Date1992-05-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884523000822 K914190 000
20884523000846 K914190 000
20884523000778 K914190 000

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