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FDA 510(k)

WOUNDWASH SALINE SPRAY

K-Number: K123910 · 2013-10-29

ApplicantNeilmed Pharmaceuticals, Inc.
Decision Date2013-10-29
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

WOUNDWASH SALINE SPRAY is the device name listed in this FDA 510(k) record. The listed applicant is Neilmed Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2013-10-29 under 510(k) number K123910. 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.

Frequently Asked Questions

What is the WOUNDWASH SALINE SPRAY?

WOUNDWASH SALINE SPRAY is a medical device that received FDA 510(k) clearance on 2013-10-29. The listed applicant is Neilmed Pharmaceuticals, Inc.. The 510(k) number is K123910.

When did WOUNDWASH SALINE SPRAY receive FDA 510(k) clearance?

WOUNDWASH SALINE SPRAY received FDA 510(k) clearance on 2013-10-29, under 510(k) number K123910.

Who is the listed applicant for WOUNDWASH SALINE SPRAY?

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

What is the FDA product code for WOUNDWASH SALINE SPRAY?

The FDA product code for WOUNDWASH SALINE SPRAY is FRO. This falls under the Anesthesiology category.

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Official Source

View on FDA Database →

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

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