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FDA 510(k)

ELASTO-GEL MANUKA HONEY WOUND DRESSING

K-Number: K083334 · 2009-07-30

ApplicantSouthwest Technologies, Inc.
Decision Date2009-07-30
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ELASTO-GEL MANUKA HONEY WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Southwest Technologies, Inc.. It received FDA 510(k) clearance on 2009-07-30 under 510(k) number K083334. 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 ELASTO-GEL MANUKA HONEY WOUND DRESSING?

ELASTO-GEL MANUKA HONEY WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2009-07-30. The listed applicant is Southwest Technologies, Inc.. The 510(k) number is K083334.

When did ELASTO-GEL MANUKA HONEY WOUND DRESSING receive FDA 510(k) clearance?

ELASTO-GEL MANUKA HONEY WOUND DRESSING received FDA 510(k) clearance on 2009-07-30, under 510(k) number K083334.

Who is the listed applicant for ELASTO-GEL MANUKA HONEY WOUND DRESSING?

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

What is the FDA product code for ELASTO-GEL MANUKA HONEY WOUND DRESSING?

The FDA product code for ELASTO-GEL MANUKA HONEY WOUND 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 Southwest Technologies, 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.

K102478OTC ELASTO-GEL MANUKA HONEY WOUND DRESSINGK030774STIMULEN COLLAGENK872488ELASTO-GEL CAST & SPLINT PADSK872165ELASTO-GEL OCCLUSIVE DRESSING

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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