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FDA 510(k)

NORMLGEL PROTECTIVE WOUND GEL

K-Number: K905438 · 1991-04-01

ApplicantScott Health Care
Decision Date1991-04-01
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

NORMLGEL PROTECTIVE WOUND GEL is the device name listed in this FDA 510(k) record. The listed applicant is Scott Health Care. It received FDA 510(k) clearance on 1991-04-01 under 510(k) number K905438. 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 NORMLGEL PROTECTIVE WOUND GEL?

NORMLGEL PROTECTIVE WOUND GEL is a medical device that received FDA 510(k) clearance on 1991-04-01. The listed applicant is Scott Health Care. The 510(k) number is K905438.

When did NORMLGEL PROTECTIVE WOUND GEL receive FDA 510(k) clearance?

NORMLGEL PROTECTIVE WOUND GEL received FDA 510(k) clearance on 1991-04-01, under 510(k) number K905438.

Who is the listed applicant for NORMLGEL PROTECTIVE WOUND GEL?

The FDA 510(k) record lists Scott Health Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORMLGEL PROTECTIVE WOUND GEL?

The FDA product code for NORMLGEL PROTECTIVE WOUND GEL is FRO. This falls under the Anesthesiology category.

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Other records listing Scott Health Care 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.

K954275MEPORE PLUS (9X15CM)K954274MEPORE (6X7)K945206ALLDRESS MULTI LAYERED WOUND DRESSINGK932743MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATIONK905439HYPERGEL PROTECTIVE WOUND GELK910857ALLDRESS MULTI LAYERED WOUND DRESSING

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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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