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FDA 510(k)

DAMOR CREAM SATURATED DRESSING

K-Number: K891097 · 1989-08-25

ApplicantDamor America, Inc.
Decision Date1989-08-25
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

DAMOR CREAM SATURATED DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Damor America, Inc.. It received FDA 510(k) clearance on 1989-08-25 under 510(k) number K891097. 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 DAMOR CREAM SATURATED DRESSING?

DAMOR CREAM SATURATED DRESSING is a medical device that received FDA 510(k) clearance on 1989-08-25. The listed applicant is Damor America, Inc.. The 510(k) number is K891097.

When did DAMOR CREAM SATURATED DRESSING receive FDA 510(k) clearance?

DAMOR CREAM SATURATED DRESSING received FDA 510(k) clearance on 1989-08-25, under 510(k) number K891097.

Who is the listed applicant for DAMOR CREAM SATURATED DRESSING?

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

What is the FDA product code for DAMOR CREAM SATURATED DRESSING?

The FDA product code for DAMOR CREAM SATURATED 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 Damor America, 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.

K934267DAMOR CREAM SATURATED DRESSINGK933328DAMOR CREMEK901022POWERED INFLATABLE TUBE MASSAGER, SPORT-MED

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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