SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle

Needle, Conduction, Anesthetic (w/wo Introducer)

SPECTRA MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Spectra Medical Devices, Inc. with the FDA for Spectra Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle.

Pre-market Notification Details

• Device ID: K151069
• 510k Number: K151069
• Device Name: SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
• Classification: Needle, Conduction, Anesthetic (w/wo Introducer)
• Applicant: SPECTRA MEDICAL DEVICES, INC. 260 F/H Fordham Road Wilmington, MA 01887
• Contact: Agustin Turriza
• Correspondent: Tanya O'brien; AJW Technology Consultants, Inc. 445 Apollo Beach Blvd Apollo Beach, FL 33572
• Product Code: BSP
• CFR Regulation Number: 868.5150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-04-21
• Decision Date: 2016-02-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M661S80C21400	K151069	000
M661S80C21200	K151069	000