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FDA 510(k)

QUALTEX ISLAND DRESSING

K-Number: K910657 · 1991-07-01

ApplicantDeroyal Industries, Inc.
Decision Date1991-07-01
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

QUALTEX ISLAND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1991-07-01 under 510(k) number K910657. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUALTEX ISLAND DRESSING?

QUALTEX ISLAND DRESSING is a medical device that received FDA 510(k) clearance on 1991-07-01. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K910657.

When did QUALTEX ISLAND DRESSING receive FDA 510(k) clearance?

QUALTEX ISLAND DRESSING received FDA 510(k) clearance on 1991-07-01, under 510(k) number K910657.

Who is the listed applicant for QUALTEX ISLAND DRESSING?

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

What is the FDA product code for QUALTEX ISLAND DRESSING?

The FDA product code for QUALTEX ISLAND DRESSING is KGX.

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Related Devices (Code: KGX)

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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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