BRAIN BIOPSY NEEDLE

Neurological Stereotaxic Instrument

AD-TECH MEDICAL INSTRUMENT CORP.

The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corp. with the FDA for Brain Biopsy Needle.

Pre-market Notification Details

Device IDK112094
510k NumberK112094
Device Name:BRAIN BIOPSY NEEDLE
ClassificationNeurological Stereotaxic Instrument
Applicant AD-TECH MEDICAL INSTRUMENT CORP. 800 LEVANGER LANE Stoughton,  WI  53589
ContactGary J Syring
CorrespondentGary J Syring
AD-TECH MEDICAL INSTRUMENT CORP. 800 LEVANGER LANE Stoughton,  WI  53589
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-22
Decision Date2012-04-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841823106674 K112094 000

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