SAFETY BIOPSY NEEDLE SYSTEM

Biopsy Needle

PFM MEDICAL, INC

The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for Safety Biopsy Needle System.

Pre-market Notification Details

Device IDK140137
510k NumberK140137
Device Name:SAFETY BIOPSY NEEDLE SYSTEM
ClassificationBiopsy Needle
Applicant PFM MEDICAL, INC 1815 ASTON AVE, SUITE 106 Carlsbad,  CA  92008
ContactSalvadore Palomares
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeFCG  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2014-01-22
Decision Date2014-03-25
Summary:summary

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