AUTOMATED CORE BIOPSY DEVICE

Biopsy Needle

PROMEX, INC.

The following data is part of a premarket notification filed by Promex, Inc. with the FDA for Automated Core Biopsy Device.

Pre-market Notification Details

Device IDK011270
510k NumberK011270
Device Name:AUTOMATED CORE BIOPSY DEVICE
ClassificationBiopsy Needle
Applicant PROMEX, INC. 3049 HUDSON ST. Franklin,  IN  46131
ContactJoseph L Mark
CorrespondentJoseph L Mark
PROMEX, INC. 3049 HUDSON ST. Franklin,  IN  46131
Product CodeFCG  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-26
Decision Date2001-06-22

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