02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360— 510(k) K913079

Name: FDA 510(k) clearance K913079
Creator: U.S. Food and Drug Administration
Published: 1991-09-25

Substantially Equivalent

Lucas Sensing Systems, Inc.

FDA 510(k) clearance K913079 for 02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360, Substantially Equivalent on 1991-09-25. Applicant: Lucas Sensing Systems, Inc.. Device class: 1.

Clearance details

Applicant: Lucas Sensing Systems, Inc.
Product code: Code KQX
Device class: Class 1
Regulation: 21 CFR 888.1500
Advisory panel: Orthopedic
Date received: 1991-07-11
Decision date: 1991-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

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