FDA 510(k)

SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE

K-Number: K103740 · 2011-07-29

Decision Date2011-07-29

Product CodeNGT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE 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 2011-07-29 under 510(k) number K103740. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE?

SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE is a medical device that received FDA 510(k) clearance on 2011-07-29. The listed applicant is Spectra Medical Devices, Inc.. The 510(k) number is K103740.

When did SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE receive FDA 510(k) clearance?

SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE received FDA 510(k) clearance on 2011-07-29, under 510(k) number K103740.

Who is the listed applicant for SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE?

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 SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE?

The FDA product code for SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE is NGT.

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Other records listing Spectra Medical Devices, Inc. as applicant

K151069SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle 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 K081524SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L

Related Devices (Code: NGT)

K2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeBecton, Dickinson and Company K233623Praxiject™ SP 0.9% NaClMedxl, Inc.K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt. , Ltd.K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd.K230756TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd.K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd.

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.