AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH

Laryngoscope, Endoscope

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 Disposable Endoscopic Specimen Pouch.

Pre-market Notification Details

Device IDK922123
510k NumberK922123
Device Name:AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH
ClassificationLaryngoscope, Endoscope
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
ContactNada Maric
CorrespondentNada Maric
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
Product CodeGCI  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-06
Decision Date1993-02-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884523000952 K922123 000
20884523000945 K922123 000

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