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FDA 510(k)

UNNA BOOT DRESSING W/CALAMINE

K-Number: K883224 · 1989-01-05

ApplicantGraham-Field, Inc.
Decision Date1989-01-05
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

UNNA BOOT DRESSING W/CALAMINE is the device name listed in this FDA 510(k) record. The listed applicant is Graham-Field, Inc.. It received FDA 510(k) clearance on 1989-01-05 under 510(k) number K883224. 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 UNNA BOOT DRESSING W/CALAMINE?

UNNA BOOT DRESSING W/CALAMINE is a medical device that received FDA 510(k) clearance on 1989-01-05. The listed applicant is Graham-Field, Inc.. The 510(k) number is K883224.

When did UNNA BOOT DRESSING W/CALAMINE receive FDA 510(k) clearance?

UNNA BOOT DRESSING W/CALAMINE received FDA 510(k) clearance on 1989-01-05, under 510(k) number K883224.

Who is the listed applicant for UNNA BOOT DRESSING W/CALAMINE?

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

What is the FDA product code for UNNA BOOT DRESSING W/CALAMINE?

The FDA product code for UNNA BOOT DRESSING W/CALAMINE is FRO. This falls under the Anesthesiology category.

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Other records listing Graham-Field, 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.

K970035JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009K961857LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060K924876TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIEDK904904MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATIONK901947CARDISUNY 501ABK901948CARDISUNY 501BIII

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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.

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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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