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FDA 510(k)

TEGASORB(TM) ULCER DRESSING, #90-XXX

K-Number: K891288 · 1989-06-09

Applicant3M Company
Decision Date1989-06-09
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

TEGASORB(TM) ULCER DRESSING, #90-XXX is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 1989-06-09 under 510(k) number K891288. 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 TEGASORB(TM) ULCER DRESSING, #90-XXX?

TEGASORB(TM) ULCER DRESSING, #90-XXX is a medical device that received FDA 510(k) clearance on 1989-06-09. The listed applicant is 3M Company. The 510(k) number is K891288.

When did TEGASORB(TM) ULCER DRESSING, #90-XXX receive FDA 510(k) clearance?

TEGASORB(TM) ULCER DRESSING, #90-XXX received FDA 510(k) clearance on 1989-06-09, under 510(k) number K891288.

Who is the listed applicant for TEGASORB(TM) ULCER DRESSING, #90-XXX?

The FDA 510(k) record lists 3M Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEGASORB(TM) ULCER DRESSING, #90-XXX?

The FDA product code for TEGASORB(TM) ULCER DRESSING, #90-XXX 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.

Other records listing 3M Company 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.

View all 322 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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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