EMS SWISS ORTHOCLAST— 510(k) K991588

Name: FDA 510(k) clearance K991588
Creator: U.S. Food and Drug Administration
Published: 1999-07-21

Substantially Equivalent

(Ems Sa) Electro Medical Systems

FDA 510(k) clearance K991588 for EMS SWISS ORTHOCLAST, Substantially Equivalent on 1999-07-21. Applicant: (Ems Sa) Electro Medical Systems. Device class: 1.

Clearance details

Applicant: (Ems Sa) Electro Medical Systems
Product code: Code HSZ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1999-05-07
Decision date: 1999-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, 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.