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FDA 510(k)

NON-ADHERING DRESSING WITH POVIDONE-IODINE

K-Number: K861384 · 1986-07-01

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1986-07-01
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

NON-ADHERING DRESSING WITH POVIDONE-IODINE 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 1986-07-01 under 510(k) number K861384. 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 NON-ADHERING DRESSING WITH POVIDONE-IODINE?

NON-ADHERING DRESSING WITH POVIDONE-IODINE is a medical device that received FDA 510(k) clearance on 1986-07-01. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K861384.

When did NON-ADHERING DRESSING WITH POVIDONE-IODINE receive FDA 510(k) clearance?

NON-ADHERING DRESSING WITH POVIDONE-IODINE received FDA 510(k) clearance on 1986-07-01, under 510(k) number K861384.

Who is the listed applicant for NON-ADHERING DRESSING WITH POVIDONE-IODINE?

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 NON-ADHERING DRESSING WITH POVIDONE-IODINE?

The FDA product code for NON-ADHERING DRESSING WITH POVIDONE-IODINE 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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