QUICK-CARE BIOPSY NEEDLE

Instrument, Biopsy

COOK, INC.

The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Quick-care Biopsy Needle.

Pre-market Notification Details

Device IDK973565
510k NumberK973565
Device Name:QUICK-CARE BIOPSY NEEDLE
ClassificationInstrument, Biopsy
Applicant COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington,  IN  47402
ContactApril Lavender
CorrespondentApril Lavender
COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington,  IN  47402
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-19
Decision Date1997-11-03
Summary:summary

NIH GUDID Devices

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