PS System— 510(k) K211721

Substantially Equivalent

Inter-Med, Inc.

FDA 510(k) clearance K211721 for PS System, Substantially Equivalent on 2021-12-02. Applicant: Inter-Med, Inc.. Device class: 1.

Clearance details

Applicant: Inter-Med, Inc.
Product code: Code NYL
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2021-06-04
Decision date: 2021-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Racine, WI, 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.