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FDA 510(k)

DERMAASSIST HYDROCOLLOID DRESSING

K-Number: K941149 · 1994-05-20

ApplicantWilshire Medical Products
Decision Date1994-05-20
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

DERMAASSIST HYDROCOLLOID DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Wilshire Medical Products. It received FDA 510(k) clearance on 1994-05-20 under 510(k) number K941149. 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 for Some Indications.

Frequently Asked Questions

What is the DERMAASSIST HYDROCOLLOID DRESSING?

DERMAASSIST HYDROCOLLOID DRESSING is a medical device that received FDA 510(k) clearance on 1994-05-20. The listed applicant is Wilshire Medical Products. The 510(k) number is K941149.

When did DERMAASSIST HYDROCOLLOID DRESSING receive FDA 510(k) clearance?

DERMAASSIST HYDROCOLLOID DRESSING received FDA 510(k) clearance on 1994-05-20, under 510(k) number K941149.

Who is the listed applicant for DERMAASSIST HYDROCOLLOID DRESSING?

The FDA 510(k) record lists Wilshire Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMAASSIST HYDROCOLLOID DRESSING?

The FDA product code for DERMAASSIST HYDROCOLLOID DRESSING is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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Other records listing Wilshire Medical Products 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.

K946030DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSINGK946031DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSINGK944333HYDRODERM GEL WOUND DRESSINGK941216HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSINGK941005DERMASSIST(TM) XEROFORM PETROLATUM DRESSINGK940044DERMASSIST WET DRESSING, SALINE

View all 12 devices →

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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