NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER

Guide, Surgical, Instrument

NORTH AMERICAN INSTRUMENT CORP.

The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Namic Homer Mammalok Needle/wire Localizer.

Pre-market Notification Details

Device IDK852402
510k NumberK852402
Device Name:NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER
ClassificationGuide, Surgical, Instrument
Applicant NORTH AMERICAN INSTRUMENT CORP. Hudson Falls,  NY  12839
ContactPhilip H Morse
CorrespondentPhilip H Morse
NORTH AMERICAN INSTRUMENT CORP. Hudson Falls,  NY  12839
Product CodeFZX  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-06-06
Decision Date1985-07-11

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