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FDA 510(k)

APTUS BLUE

K-Number: K030884 · 2003-05-27

ApplicantAcadental
Decision Date2003-05-27
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

APTUS BLUE is the device name listed in this FDA 510(k) record. The listed applicant is Acadental. It received FDA 510(k) clearance on 2003-05-27 under 510(k) number K030884. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APTUS BLUE?

APTUS BLUE is a medical device that received FDA 510(k) clearance on 2003-05-27. The listed applicant is Acadental. The 510(k) number is K030884.

When did APTUS BLUE receive FDA 510(k) clearance?

APTUS BLUE received FDA 510(k) clearance on 2003-05-27, under 510(k) number K030884.

Who is the listed applicant for APTUS BLUE?

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

What is the FDA product code for APTUS BLUE?

The FDA product code for APTUS BLUE is KJJ.

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Related Devices (Code: KJJ)

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.

K250279RC-SwiftPrepBelport Company, Inc., Gingi-PakK241354Sealer SolventInter-Med, Inc.K201785EPIEN Dental CleanserEpien Medical, Inc.K211813TritonInter-Med / Vista DentalK193357V-MixInter-Med/Vista Dental ProductsK193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products

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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