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FDA 510(k)

CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING

K-Number: K123394 · 2013-06-06

ApplicantCoreleader Biotech Co., Ltd.
Decision Date2013-06-06
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Coreleader Biotech Co., Ltd.. It received FDA 510(k) clearance on 2013-06-06 under 510(k) number K123394. 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 CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING?

CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2013-06-06. The listed applicant is Coreleader Biotech Co., Ltd.. The 510(k) number is K123394.

When did CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING receive FDA 510(k) clearance?

CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING received FDA 510(k) clearance on 2013-06-06, under 510(k) number K123394.

Who is the listed applicant for CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING?

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

What is the FDA product code for CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING?

The FDA product code for CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Coreleader Biotech Co., 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.

K111578CORELEADER COLLA-ALGI FIBER MODEL CAWK111733CORELEADER SCAR-DIMMERK102944CORELEADER HEMO-PAD MODEL CPII 02030K102942CORELEADER ALGIPLASTER MODEL AP 050501K102946CORELEADER COLLA-PAD MODEL CS 03030K102943CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050

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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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