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FDA 510(k)

TL-CERMIDE SKIN BARRIER EMULSION

K-Number: K110757 · 2011-08-19

ApplicantTrigen Laboratories, Inc.
Decision Date2011-08-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

TL-CERMIDE SKIN BARRIER EMULSION is the device name listed in this FDA 510(k) record. The listed applicant is Trigen Laboratories, Inc.. It received FDA 510(k) clearance on 2011-08-19 under 510(k) number K110757. 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 TL-CERMIDE SKIN BARRIER EMULSION?

TL-CERMIDE SKIN BARRIER EMULSION is a medical device that received FDA 510(k) clearance on 2011-08-19. The listed applicant is Trigen Laboratories, Inc.. The 510(k) number is K110757.

When did TL-CERMIDE SKIN BARRIER EMULSION receive FDA 510(k) clearance?

TL-CERMIDE SKIN BARRIER EMULSION received FDA 510(k) clearance on 2011-08-19, under 510(k) number K110757.

Who is the listed applicant for TL-CERMIDE SKIN BARRIER EMULSION?

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

What is the FDA product code for TL-CERMIDE SKIN BARRIER EMULSION?

The FDA product code for TL-CERMIDE SKIN BARRIER EMULSION is FRO. This falls under the Anesthesiology category.

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Other records listing Trigen Laboratories, 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.

K121134TL TRISEB CREAMK110762AVO BARRIER TOPICAL EMULSION

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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