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FDA 510(k)

CONCEPT II

K-Number: K790339 · 1979-07-17

ApplicantRichardson Merrel, Inc.
Decision Date1979-07-17
Product CodeEBE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CONCEPT II is the device name listed in this FDA 510(k) record. The listed applicant is Richardson Merrel, Inc.. It received FDA 510(k) clearance on 1979-07-17 under 510(k) number K790339. The device is classified under product code EBE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONCEPT II?

CONCEPT II is a medical device that received FDA 510(k) clearance on 1979-07-17. The listed applicant is Richardson Merrel, Inc.. The 510(k) number is K790339.

When did CONCEPT II receive FDA 510(k) clearance?

CONCEPT II received FDA 510(k) clearance on 1979-07-17, under 510(k) number K790339.

Who is the listed applicant for CONCEPT II?

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

What is the FDA product code for CONCEPT II?

The FDA product code for CONCEPT II is EBE.

Related Clinical Trials

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.

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Other records listing Richardson Merrel, 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.

K780254DENTURE CLEANSER & TOOTHPASTE IN ONE

Related Devices (Code: EBE)

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.

K832500CS-11Chema-Scutum, Inc.K830491JOHNSON & JOHNSON OPAQUE COLOR MODIFIJohnson & Johnson Professionals, Inc.

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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