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FDA 510(k)

PARKELL RESIN GLAZE

K-Number: K040599 · 2004-04-09

ApplicantParkell, Inc.
Decision Date2004-04-09
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PARKELL RESIN GLAZE is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2004-04-09 under 510(k) number K040599. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARKELL RESIN GLAZE?

PARKELL RESIN GLAZE is a medical device that received FDA 510(k) clearance on 2004-04-09. The listed applicant is Parkell, Inc.. The 510(k) number is K040599.

When did PARKELL RESIN GLAZE receive FDA 510(k) clearance?

PARKELL RESIN GLAZE received FDA 510(k) clearance on 2004-04-09, under 510(k) number K040599.

Who is the listed applicant for PARKELL RESIN GLAZE?

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

What is the FDA product code for PARKELL RESIN GLAZE?

The FDA product code for PARKELL RESIN GLAZE is EBD.

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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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