FDA 510(k)

SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L

K-Number: K081524 · 2008-07-29

Decision Date2008-07-29

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L is the device name listed in this FDA 510(k) record. The listed applicant is Spectra Medical Devices, Inc.. It received FDA 510(k) clearance on 2008-07-29 under 510(k) number K081524. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L?

SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L is a medical device that received FDA 510(k) clearance on 2008-07-29. The listed applicant is Spectra Medical Devices, Inc.. The 510(k) number is K081524.

When did SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L receive FDA 510(k) clearance?

SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L received FDA 510(k) clearance on 2008-07-29, under 510(k) number K081524.

Who is the listed applicant for SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L?

The FDA 510(k) record lists Spectra Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L?

The FDA product code for SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L is FMF.

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Other records listing Spectra Medical Devices, Inc. as applicant

K151069SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle K103740SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE K082689STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE K082580SPECTRA GUIDEWIRE INTRODUCER NEEDLE K082674SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE

Related Devices (Code: FMF)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.