ECHOTIP ULTRA ULTRASOUND NEEDLE

Biopsy Needle

COOK ENDOSCOPY

The following data is part of a premarket notification filed by Cook Endoscopy with the FDA for Echotip Ultra Ultrasound Needle.

Pre-market Notification Details

Device IDK083330
510k NumberK083330
Device Name:ECHOTIP ULTRA ULTRASOUND NEEDLE
ClassificationBiopsy Needle
Applicant COOK ENDOSCOPY 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem,  NC  27105
ContactScottie Fariole
CorrespondentScottie Fariole
COOK ENDOSCOPY 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem,  NC  27105
Product CodeFCG  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-12
Decision Date2009-02-06
Summary:summary

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