CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE

Electrode, Needle

NICOLET BIOMEDICAL INSTRUMENTS

The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Concentric Needle Electrodes-various Sizes W/conne.

Pre-market Notification Details

• Device ID: K850107
• 510k Number: K850107
• Device Name: CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE
• Classification: Electrode, Needle
• Applicant: NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison, WI 53711
• Contact: Ron Luich
• Correspondent: Ron Luich; NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison, WI 53711
• Product Code: GXZ
• CFR Regulation Number: 882.1350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-01-10
• Decision Date: 1985-04-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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20681490176914	K850107	000
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00613994896742	K850107	000