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510(k) K082674

SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE by Spectra Medical Devices, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2008
Date Received
September 15, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Spectra Medical Devices, Inc.

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  • 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)
  • K081524 — SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PL (July 29, 2008)

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