FDA 510(k)

DEROYAL GOWNS, STERILE, NON-STERILE

K-Number: K030364 · 2003-04-28

Decision Date2003-04-28

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DEROYAL GOWNS, STERILE, NON-STERILE 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 2003-04-28 under 510(k) number K030364. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEROYAL GOWNS, STERILE, NON-STERILE?

DEROYAL GOWNS, STERILE, NON-STERILE is a medical device that received FDA 510(k) clearance on 2003-04-28. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K030364.

When did DEROYAL GOWNS, STERILE, NON-STERILE receive FDA 510(k) clearance?

DEROYAL GOWNS, STERILE, NON-STERILE received FDA 510(k) clearance on 2003-04-28, under 510(k) number K030364.

Who is the listed applicant for DEROYAL GOWNS, STERILE, NON-STERILE?

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 DEROYAL GOWNS, STERILE, NON-STERILE?

The FDA product code for DEROYAL GOWNS, STERILE, NON-STERILE is FYA.

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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.