VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP

Laparoscope, General & Plastic Surgery

COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR

The following data is part of a premarket notification filed by Covidien Lp, Formerly Registered As Tyco Healthcar with the FDA for Versaport Bladeless Low Profile Trocar Model Nb3shflp, Nb5shflp, Nb5stflp.

Pre-market Notification Details

Device IDK100548
510k NumberK100548
Device Name:VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP
ClassificationLaparoscope, General & Plastic Surgery
Applicant COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR 60 MIDDLETOWN AVENUE North Haven,  CT  06473
ContactAngela Van Arsdale
CorrespondentAngela Van Arsdale
COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR 60 MIDDLETOWN AVENUE North Haven,  CT  06473
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-26
Decision Date2010-04-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521076744 K100548 000
20884521076737 K100548 000
20884521076720 K100548 000
20884521073514 K100548 000
20884521073507 K100548 000
20884521070469 K100548 000
20884521070438 K100548 000
20884521070391 K100548 000

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