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FDA 510(k)

JELONET PARAFFIN GAUZE DRESSINGS

K-Number: K791573 · 1979-09-04

ApplicantAcme United Corp.
Decision Date1979-09-04
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

JELONET PARAFFIN GAUZE DRESSINGS is the device name listed in this FDA 510(k) record. The listed applicant is Acme United Corp.. It received FDA 510(k) clearance on 1979-09-04 under 510(k) number K791573. 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 JELONET PARAFFIN GAUZE DRESSINGS?

JELONET PARAFFIN GAUZE DRESSINGS is a medical device that received FDA 510(k) clearance on 1979-09-04. The listed applicant is Acme United Corp.. The 510(k) number is K791573.

When did JELONET PARAFFIN GAUZE DRESSINGS receive FDA 510(k) clearance?

JELONET PARAFFIN GAUZE DRESSINGS received FDA 510(k) clearance on 1979-09-04, under 510(k) number K791573.

Who is the listed applicant for JELONET PARAFFIN GAUZE DRESSINGS?

The FDA 510(k) record lists Acme United Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JELONET PARAFFIN GAUZE DRESSINGS?

The FDA product code for JELONET PARAFFIN GAUZE DRESSINGS is FRO. This falls under the Anesthesiology category.

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Other records listing Acme United Corp. as applicant

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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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