FDA 510(k)

COMP. E

K-Number: K032179 · 2003-09-09

Decision Date2003-09-09

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

COMP. E is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2003-09-09 under 510(k) number K032179. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMP. E?

COMP. E is a medical device that received FDA 510(k) clearance on 2003-09-09. The listed applicant is Parkell, Inc.. The 510(k) number is K032179.

When did COMP. E receive FDA 510(k) clearance?

COMP. E received FDA 510(k) clearance on 2003-09-09, under 510(k) number K032179.

Who is the listed applicant for COMP. E?

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 COMP. E?

The FDA product code for COMP. E is KLE.

Other records listing Parkell, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243254Parkell Pit and Fissure Sealant K210259Parkell Self-Adhesive Cement K191103Parkell Desensitizer Gel K190930SmarTemp X1 K182296HyperFil-LV K172176Parkell Universal Adhesive

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Related Devices (Code: KLE)

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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.