NEBULAE I

Insufflator, Laparoscopic

NORTHGATE TECHNOLOGIES INC.

The following data is part of a premarket notification filed by Northgate Technologies Inc. with the FDA for Nebulae I.

Pre-market Notification Details

Device IDK120151
510k NumberK120151
Device Name:NEBULAE I
ClassificationInsufflator, Laparoscopic
Applicant NORTHGATE TECHNOLOGIES INC. 1591 SCOTTSDALE COURT Elgin,  IL  60123
ContactCasey Kurek
CorrespondentCasey Kurek
NORTHGATE TECHNOLOGIES INC. 1591 SCOTTSDALE COURT Elgin,  IL  60123
Product CodeHIF  
Subsequent Product CodeFCX
Subsequent Product CodeOSX
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-18
Decision Date2012-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885554032352 K120151 000
00885554032345 K120151 000
03596010673497 K120151 000

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