FDA 510(k)

20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE

K-Number: K972185 · 1998-03-05

Decision Date1998-03-05

Product CodeFRO

DecisionSubstantially Equivalent for Some Indications

Device Summary

20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE is the device name listed in this FDA 510(k) record. The listed applicant is Steripak, Ltd.. It received FDA 510(k) clearance on 1998-03-05 under 510(k) number K972185. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the 20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE?

20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE is a medical device that received FDA 510(k) clearance on 1998-03-05. The listed applicant is Steripak, Ltd.. The 510(k) number is K972185.

When did 20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE receive FDA 510(k) clearance?

20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE received FDA 510(k) clearance on 1998-03-05, under 510(k) number K972185.

Who is the listed applicant for 20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE?

The FDA 510(k) record lists Steripak, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE?

The FDA product code for 20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE is FRO. This falls under the Anesthesiology category.

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Other records listing Steripak, Ltd. as applicant

K9808293ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP

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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.