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FDA 510(k)

J & J ULCER DRESSING

K-Number: K850451 · 1985-06-05

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1985-06-05
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

J & J ULCER DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1985-06-05 under 510(k) number K850451. 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 J & J ULCER DRESSING?

J & J ULCER DRESSING is a medical device that received FDA 510(k) clearance on 1985-06-05. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K850451.

When did J & J ULCER DRESSING receive FDA 510(k) clearance?

J & J ULCER DRESSING received FDA 510(k) clearance on 1985-06-05, under 510(k) number K850451.

Who is the listed applicant for J & J ULCER DRESSING?

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

What is the FDA product code for J & J ULCER DRESSING?

The FDA product code for J & J ULCER DRESSING is FRO. This falls under the Anesthesiology category.

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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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