HEALTHTRONIC OMEGA TRAC— 510(k) K881902

Name: FDA 510(k) clearance K881902
Creator: U.S. Food and Drug Administration
Published: 1988-06-22

Substantially Equivalent

Healthtronics Surgical Services, Inc.

FDA 510(k) clearance K881902 for HEALTHTRONIC OMEGA TRAC, Substantially Equivalent on 1988-06-22. Applicant: Healthtronics Surgical Services, Inc.. Device class: 2.

Clearance details

Applicant: Healthtronics Surgical Services, Inc.
Product code: Code JFB
Device class: Class 2
Regulation: 21 CFR 890.5880
Advisory panel: Physical Medicine
Date received: 1988-05-06
Decision date: 1988-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Cordova, CA, US

Download summary PDF View on FDA.gov ↗

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