ENDOSCOPE SUTURE & CARRIER

Laparoscope, General & Plastic Surgery

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 Endoscope Suture & Carrier.

Pre-market Notification Details

Device IDK912973
510k NumberK912973
Device Name:ENDOSCOPE SUTURE & CARRIER
ClassificationLaparoscope, General & Plastic Surgery
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 CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-08
Decision Date1991-09-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521132082 K912973 000
20884521132105 K912973 000
20884521174976 K912973 000
20884521132068 K912973 000
20884521132020 K912973 000
20884521132037 K912973 000
20884521132051 K912973 000
20884521183640 K912973 000
20884521132013 K912973 000
20884521132112 K912973 000

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