VTI SUCTION IRRIGATION SYSTEM

Laparoscope, General & Plastic Surgery

REGULATORY TECHNOLOGY SERVICES, LLC

The following data is part of a premarket notification filed by Regulatory Technology Services, Llc with the FDA for Vti Suction Irrigation System.

Pre-market Notification Details

Device IDK141323
510k NumberK141323
Device Name:VTI SUCTION IRRIGATION SYSTEM
ClassificationLaparoscope, General & Plastic Surgery
Applicant REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
ContactMark Job
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2014-05-20
Decision Date2014-06-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817122020430 K141323 000
00817122020423 K141323 000
00817122020416 K141323 000
00817122020065 K141323 000
10817122020475 K141323 000
10817122020031 K141323 000
00817122020522 K141323 000
00817122020515 K141323 000

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