NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)

Set, Administration, Intravascular

NORTH AMERICAN INSTRUMENT CORP.

The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Namic Contrast & Fluid Delivery Spikes(various).

Pre-market Notification Details

Device IDK852140
510k NumberK852140
Device Name:NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)
ClassificationSet, Administration, Intravascular
Applicant NORTH AMERICAN INSTRUMENT CORP. Hudson Falls,  NY  12839
ContactPhillip H Morse
CorrespondentPhillip H Morse
NORTH AMERICAN INSTRUMENT CORP. Hudson Falls,  NY  12839
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-16
Decision Date1985-05-30

NIH GUDID Devices

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