FDA 510(k)

RE NU

K-Number: K973289 · 1999-02-09

Decision Date1999-02-09

Product CodeEJR

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

RE NU is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Rim Dental, Inc.. It received FDA 510(k) clearance on 1999-02-09 under 510(k) number K973289. The device is classified under product code EJR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RE NU?

RE NU is a medical device that received FDA 510(k) clearance on 1999-02-09. The listed applicant is Pacific Rim Dental, Inc.. The 510(k) number is K973289.

When did RE NU receive FDA 510(k) clearance?

RE NU received FDA 510(k) clearance on 1999-02-09, under 510(k) number K973289.

Who is the listed applicant for RE NU?

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

What is the FDA product code for RE NU?

The FDA product code for RE NU is EJR.

Other records listing Pacific Rim Dental, 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.

K972871GENESIS

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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.