GENESIS— 510(k) K972871

Substantially Equivalent

Pacific Rim Dental, Inc.

FDA 510(k) clearance K972871 for GENESIS, Substantially Equivalent on 1997-10-02. Applicant: Pacific Rim Dental, Inc.. Device class: 2.

Clearance details

Applicant: Pacific Rim Dental, Inc.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1997-08-04
Decision date: 1997-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stateline, NV, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.