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FDA 510(k)

HYLATOPIC PLUS EMOLLIENT FOAM

K-Number: K093051 · 2009-12-07

ApplicantCollegium Pharmaceutical Incorporated
Decision Date2009-12-07
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

HYLATOPIC PLUS EMOLLIENT FOAM is the device name listed in this FDA 510(k) record. The listed applicant is Collegium Pharmaceutical Incorporated. It received FDA 510(k) clearance on 2009-12-07 under 510(k) number K093051. 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 HYLATOPIC PLUS EMOLLIENT FOAM?

HYLATOPIC PLUS EMOLLIENT FOAM is a medical device that received FDA 510(k) clearance on 2009-12-07. The listed applicant is Collegium Pharmaceutical Incorporated. The 510(k) number is K093051.

When did HYLATOPIC PLUS EMOLLIENT FOAM receive FDA 510(k) clearance?

HYLATOPIC PLUS EMOLLIENT FOAM received FDA 510(k) clearance on 2009-12-07, under 510(k) number K093051.

Who is the listed applicant for HYLATOPIC PLUS EMOLLIENT FOAM?

The FDA 510(k) record lists Collegium Pharmaceutical Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYLATOPIC PLUS EMOLLIENT FOAM?

The FDA product code for HYLATOPIC PLUS EMOLLIENT FOAM is FRO. This falls under the Anesthesiology category.

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Other records listing Collegium Pharmaceutical Incorporated 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.

K093320DRYODINE CADEXOMER-IODINE GELK083024HYLATOPIC EMOLLIENT FOAM

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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