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510(k) K163292

Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford by Spectra Medical Devices — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2017
Date Received
November 22, 2016
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

  • K151069 — SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle (February 5, 2016)
  • K142791 — Spectra Soft Tissue Biopsy Needles (January 21, 2015)
  • 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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