NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013— 510(k) K031173

Name: FDA 510(k) clearance K031173
Creator: U.S. Food and Drug Administration
Published: 2003-07-23

Substantially Equivalent

Needle Tech Products, Inc.

FDA 510(k) clearance K031173 for NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013, Substantially Equivalent on 2003-07-23. Applicant: Needle Tech Products, Inc.. Device class: 1.

Clearance details

Applicant: Needle Tech Products, Inc.
Product code: Code GDF
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 2003-04-14
Decision date: 2003-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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