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FDA 510(k)

WOUND FLUSH, STERILE WATER & NORMAL SALINE

K-Number: K083042 · 2008-12-18

ApplicantNurse Assist, Inc.
Decision Date2008-12-18
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

WOUND FLUSH, STERILE WATER & NORMAL SALINE is the device name listed in this FDA 510(k) record. The listed applicant is Nurse Assist, Inc.. It received FDA 510(k) clearance on 2008-12-18 under 510(k) number K083042. 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 WOUND FLUSH, STERILE WATER & NORMAL SALINE?

WOUND FLUSH, STERILE WATER & NORMAL SALINE is a medical device that received FDA 510(k) clearance on 2008-12-18. The listed applicant is Nurse Assist, Inc.. The 510(k) number is K083042.

When did WOUND FLUSH, STERILE WATER & NORMAL SALINE receive FDA 510(k) clearance?

WOUND FLUSH, STERILE WATER & NORMAL SALINE received FDA 510(k) clearance on 2008-12-18, under 510(k) number K083042.

Who is the listed applicant for WOUND FLUSH, STERILE WATER & NORMAL SALINE?

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

What is the FDA product code for WOUND FLUSH, STERILE WATER & NORMAL SALINE?

The FDA product code for WOUND FLUSH, STERILE WATER & NORMAL SALINE is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Nurse Assist, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121390LUBE JELLY SURINGE

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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