AIR-FLEX WITH AUTO-DISTRACTION— 510(k) K063034

Name: FDA 510(k) clearance K063034
Creator: U.S. Food and Drug Administration
Published: 2006-12-14

Substantially Equivalent

Hill Laboratories Co.

FDA 510(k) clearance K063034 for AIR-FLEX WITH AUTO-DISTRACTION, Substantially Equivalent on 2006-12-14. Applicant: Hill Laboratories Co.. Device class: 2.

Clearance details

Applicant: Hill Laboratories Co.
Product code: Code JFB
Device class: Class 2
Regulation: 21 CFR 890.5880
Advisory panel: Physical Medicine
Date received: 2006-10-03
Decision date: 2006-12-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Frazer, PA, US

Download summary PDF View on FDA.gov ↗

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