VS3

Laparoscope, General & Plastic Surgery

VISIONSENSE, LTD.

The following data is part of a premarket notification filed by Visionsense, Ltd. with the FDA for Vs3.

Pre-market Notification Details

Device IDK123467
510k NumberK123467
Device Name:VS3
ClassificationLaparoscope, General & Plastic Surgery
Applicant VISIONSENSE, LTD. 555 13TH STREET, NW Washington,  DC  20004
ContactGerard J Prud'homme
CorrespondentGerard J Prud'homme
VISIONSENSE, LTD. 555 13TH STREET, NW Washington,  DC  20004
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-09
Decision Date2013-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18130400103199 K123467 000
18130400103052 K123467 000
18130400103045 K123467 000

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