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FDA 510(k)

HYDROCOLLOID DRESSINGS - STERILE

K-Number: K863390 · 1986-09-30

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1986-09-30
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

HYDROCOLLOID DRESSINGS - STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1986-09-30 under 510(k) number K863390. 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 HYDROCOLLOID DRESSINGS - STERILE?

HYDROCOLLOID DRESSINGS - STERILE is a medical device that received FDA 510(k) clearance on 1986-09-30. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K863390.

When did HYDROCOLLOID DRESSINGS - STERILE receive FDA 510(k) clearance?

HYDROCOLLOID DRESSINGS - STERILE received FDA 510(k) clearance on 1986-09-30, under 510(k) number K863390.

Who is the listed applicant for HYDROCOLLOID DRESSINGS - STERILE?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDROCOLLOID DRESSINGS - STERILE?

The FDA product code for HYDROCOLLOID DRESSINGS - STERILE is FRO. This falls under the Anesthesiology category.

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Other records listing Convatec, A Division of E.R. Squibb & Sons as applicant

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Related Devices (Code: FRO)

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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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