SILS PORT MODEL SILSPT15

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 Sils Port Model Silspt15.

Pre-market Notification Details

Device IDK093372
510k NumberK093372
Device Name:SILS PORT MODEL SILSPT15
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 Received2009-10-29
Decision Date2009-12-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884523002659 K093372 000
20884523002635 K093372 000
20884523002642 K093372 000

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