ULTRA TRACTION— 510(k) K881603

Substantially Equivalent

Component Equipment Mfg., Inc.

FDA 510(k) clearance K881603 for ULTRA TRACTION, Substantially Equivalent on 1988-05-04. Applicant: Component Equipment Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Component Equipment Mfg., Inc.
Product code: Code ITH
Device class: Class 2
Regulation: 21 CFR 890.5900
Advisory panel: Physical Medicine
Date received: 1988-04-13
Decision date: 1988-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, US

Download summary PDF View on FDA.gov ↗

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