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FDA 510(k)

WEDGE PRESSURE DRESSING

K-Number: K891189 · 1989-05-24

ApplicantDurden Enterprises, Inc.
Decision Date1989-05-24
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

WEDGE PRESSURE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Durden Enterprises, Inc.. It received FDA 510(k) clearance on 1989-05-24 under 510(k) number K891189. 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 WEDGE PRESSURE DRESSING?

WEDGE PRESSURE DRESSING is a medical device that received FDA 510(k) clearance on 1989-05-24. The listed applicant is Durden Enterprises, Inc.. The 510(k) number is K891189.

When did WEDGE PRESSURE DRESSING receive FDA 510(k) clearance?

WEDGE PRESSURE DRESSING received FDA 510(k) clearance on 1989-05-24, under 510(k) number K891189.

Who is the listed applicant for WEDGE PRESSURE DRESSING?

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

What is the FDA product code for WEDGE PRESSURE DRESSING?

The FDA product code for WEDGE PRESSURE DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Durden Enterprises, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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