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FDA 510(k)

PVP GEL DRESSING

K-Number: K820635 · 1982-08-31

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1982-08-31
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PVP GEL 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 1982-08-31 under 510(k) number K820635. 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 PVP GEL DRESSING?

PVP GEL DRESSING is a medical device that received FDA 510(k) clearance on 1982-08-31. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K820635.

When did PVP GEL DRESSING receive FDA 510(k) clearance?

PVP GEL DRESSING received FDA 510(k) clearance on 1982-08-31, under 510(k) number K820635.

Who is the listed applicant for PVP GEL 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 PVP GEL DRESSING?

The FDA product code for PVP GEL DRESSING is FRO. This falls under the Anesthesiology category.

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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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