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510(k) K151069

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle by Spectra Medical Devices, Inc. — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2016
Date Received
April 21, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

Other clearances by Spectra Medical Devices, Inc.

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  • K103740 — SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE (July 29, 2011)
  • K082689 — STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE (March 20, 2009)
  • K082580 — SPECTRA GUIDEWIRE INTRODUCER NEEDLE (December 8, 2008)
  • K082674 — SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA (November 28, 2008)
  • K081524 — SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PL (July 29, 2008)

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