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FDA 510(k)

WATER-JEL(R) BURN DRESSING

K-Number: K864841 · 1988-01-22

ApplicantTrilling Resources, Ltd.
Decision Date1988-01-22
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

WATER-JEL(R) BURN DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Trilling Resources, Ltd.. It received FDA 510(k) clearance on 1988-01-22 under 510(k) number K864841. 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 WATER-JEL(R) BURN DRESSING?

WATER-JEL(R) BURN DRESSING is a medical device that received FDA 510(k) clearance on 1988-01-22. The listed applicant is Trilling Resources, Ltd.. The 510(k) number is K864841.

When did WATER-JEL(R) BURN DRESSING receive FDA 510(k) clearance?

WATER-JEL(R) BURN DRESSING received FDA 510(k) clearance on 1988-01-22, under 510(k) number K864841.

Who is the listed applicant for WATER-JEL(R) BURN DRESSING?

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

What is the FDA product code for WATER-JEL(R) BURN DRESSING?

The FDA product code for WATER-JEL(R) BURN DRESSING 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 Trilling Resources, Ltd. 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.

K800064WATER JEL FIRE BLANKET

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

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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