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FDA 510(k)

GENESIS

K-Number: K972871 · 1997-10-02

ApplicantPacific Rim Dental, Inc.
Decision Date1997-10-02
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GENESIS 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 1997-10-02 under 510(k) number K972871. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESIS?

GENESIS is a medical device that received FDA 510(k) clearance on 1997-10-02. The listed applicant is Pacific Rim Dental, Inc.. The 510(k) number is K972871.

When did GENESIS receive FDA 510(k) clearance?

GENESIS received FDA 510(k) clearance on 1997-10-02, under 510(k) number K972871.

Who is the listed applicant for GENESIS?

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 GENESIS?

The FDA product code for GENESIS is ELW.

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 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.

K973289RE NU

Related Devices (Code: ELW)

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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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.

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